Coronary Artery DiseaseABSORB JAPANNCT01844284
AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 (Absorb™ BVS) in Japanese Population
A study testing XIENCE PRIME®/XIENCE Xpedition™ and Absorb™ BVS in people with Coronary Artery Disease and Myocardial Ischemia, run by Abbott Medical Devices at 39 sites in Japan.
Trial summary
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- XIENCE PRIME®/XIENCE Xpedition™ and Absorb™ BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 39 sitesJapan
- Study dates
- Apr 2013to 16 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 20 years of age.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
- Female subject of childbearing potential must not be pregnant* at the index procedure and does not plan pregnancy for up to 1 year following the index procedure.
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- Except for non-pregnancy is apparent, negative pregnancy result within 7 days prior to the index procedure is required.
- Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
- Subject agrees to not participate in any other investigational or invasive clinical study for a period of 13 months following the index procedure
Who cannot join
- Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
- Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
- Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
- The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes
- Creatine Kinase (CK) and Creatine Kinase - Muscle and Brain (CK-MB) have not returned to within normal limits at the time of index procedure.
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- Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
- Subject has a known left ventricular ejection fraction (LVEF) < 30% (LVEF may be obtained at the time of the index procedure if the value is unknown and the investigator believes it is necessary).
- The target vessel was treated by PCI within 12 months.
- Prior PCI within the non-target vessel is acceptable if performed anytime > 30 days before the index procedure or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
- Subject requires future staged PCI either in target or non target vessels.
- Subject has a malignancy that is not in remission.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.,). Note: corticosteroids are not included as immunosuppressant therapy, diabetes mellitus is not regarded as autoimmune disease.
- Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
- Subject has previously received or scheduled to receive radiotherapy to coronary artery (brachytherapy), or chest/mediastinum.
- Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin or any other agent for any reason).
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
- Subject has a documented or suspected cirrhosis of Child-Pugh ≥ Class B.
- Subject has known renal insufficiency;
- Dialysis at the time of screening.
- An estimated Glomerular filtration rate (GFR) < 30 ml/min/1.73m2
- Subject is high risk of bleeding, or difficult to have appropriate treatment;
- Has a history of bleeding diathesis or coagulopathy
- Has had a significant gastro-intestinal or significant urinary bleed within the past six months
- Has prior intracranial bleed
- Has prior intracranial bleed (including severe permanent neurologic deficit that seem to be caused by previous intracranial bleeding)
- Has known intracranial pathology that may cause intracranial bleeding per an investigator assessment (e.g. untreated aneurysm > 5 mm, arteriovenous malformation)
- Subject will refuse blood transfusions
- Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months,
- Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
- Subject has life expectancy < 3 year.
- Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
- Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
- Subject whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g. subordinate hospital staff or sponsor staff) or subject is unable to read or write.
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
Japan39 sites
Kansairosai Hospital
Amagasaki-shi, Hyōgo, 660-8511
Juntendo University
Bunkyo-ku, Tokyo, 113-8431
University of Tokyo
Bunkyo-ku, Tokyo, 113-8655
Mitsui Memorial Museum
Chiyoda-ku, Tokyo, 101-8643
Sakakibara Memorial Hospital
Fuchu-shi, Tokyo, 183-0003
Tokai University
Isehara-shi, Kanagawa, 259-1193
Shonankamakura General Hospital
Kamakura-shi, Kanagawa, 247-8533
Kanto Rosai Hospital
Kawasaki-shi, Kanagawa, 211-8510
Wakayama Medical University Hospital
Kimiidera, Wakayama, 641-8509
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, 802-8555
Kobe University
Kobe, Hyōgo, 650-0017
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, 710-8602
Kurume University
Kurume-shi, Fukuoka, 830-0011
Shinkoga Hospital
Kurume-shi, Fukuoka, 830-8577
Kyoto University
Kyoto, Honshu, 606-8507
ShinTokyo
Matsudo-shi, Chiba, 270-2232
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, 153-8515
The Cardiovascular Institute Hospital
Minato-Ku, Tokyo, 106-0031
Miyazak Medical Association Hospital
Miyazaki, Miyazaki, 880-0834
Iwate Medical University
Morioka, Iwate, 020-8505
Nagoya Daini Red Cross Hospital
Nagoya, Aichi-ken, 466-8650
Sakurabashi Watanabe Hospital
Osaka, Osaka, 530-0001
Saitama Medical Center Jichi Medical University
Saitama-shi, Saitama, 330-8503
Hanaoka Seishu Memorial Cardiovascular Clinic
Sapporo, Hokkaido, 062-0003
Saitama Sekishinkai
Sayama-shi, Saitama, 350-1323
Showa University Hospital
Shinagawa-ku, Tokyo, 142-8666
Tokyo Women's Medical University
Shinjuku-ku, Tokyo, 162-8666
Osaka University
Suita-shi, Osaka, 565-0871
The National Cerebral and Cardiovascular Center
Suita-shi, Osaka, 565-8565
Teikyo University
tabashi City, Tokyo, 173-8606
Tenri Hospital
Tenri-shi, Nara, 632-8552
Dokkyo University
Tochigi, Utsunomiya, 321-0293
Tokushima Red Cross Hospital
Tokushima, 773-8502
Abbott Vascular Japan Co., Ltd.
Tokyo, 108-6304
Fujita Health University
Toyoake-shi, Aichi-ken, 470-1192
Tsukuba Medical Center
Tsukuba, Ibaraki, 305-8558
Yamaguchi University
Ube-shi, Yamaguchi, 755-8505
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 230-8765
About this study
Official title: A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
Read the detailed description
Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Being tested
- XIENCE PRIME®/XIENCE Xpedition™, Absorb™ BVS
- Keywords
- Absorb™ BVS, Angioplasty, Bioabsorbable, Bioreabsorbable, BVS, Coronary Artery Disease, Coronary Artery Endothelial Responsiveness, Coronary artery restenosis, Coronary artery stenosis, Coronary scaffold, Coronary Stent, Drug eluting stents, Everolimus, Myocardial ischemia, Stent thrombosis, Stents
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Coronary Restenosis, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE PRIME®/XIENCE Xpedition™Device
Subjects receiving XIENCE PRIME®/XIENCE Xpedition™
Absorb™ BVSDevice
Subjects receiving Absorb™ BVS
| Study group | Role | What they receive |
|---|---|---|
| Absorb™ BVS | Experimental | Subjects receiving Absorb™ BVS Receives: Device: Absorb™ BVS |
| XIENCE PRIME®/XIENCE Xpedition™ | Active comparator | Subjects receiving XIENCE PRIME®/XIENCE Xpedition™ Receives: Device: XIENCE PRIME®/XIENCE Xpedition™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 1 year
Secondary outcomes (101)
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 1 month
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 6 months
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 1 year
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 2 years
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 3 years
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 4 years
Number of Participants With Any Death/Any MI/Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Measured: 5 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 1 month
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 6 months
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 1 year
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 2 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 3 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 4 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Measured: 5 years
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 1 month
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 6 months
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 2 years
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 3 years
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 4 years
Number of Participants With Target Lesion Failure (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Measured: 5 years
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 1 month
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 6 months
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 1 year
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 2 years
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 3 years
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 4 years
Number of Participants With Cardiac Death/All MI
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), un witnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Myocardial Infarction (MI) Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves
Measured: 5 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 1 month
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 6 months
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 1 year
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 2 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 3 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 4 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 5 years
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 1 month
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 6 months
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 1 year
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 2 years
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 3 years
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 4 years
Number of Participants With Ischemia-driven TVR (ID-TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Measured: 5 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 1 month
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 6 months
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 1 year
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 2 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 3 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 4 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated [CI] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement.
The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Measured: 5 years
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 1 month
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 6 months
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 1 year
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 2 years
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 3 years
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 4 years
Number of Participants With Ischemia-driven Revascularization (ID-TLR)
A revascularization is considered ischemia-driven if associated with any of the following:
- Positive functional ischemia study including positive FFR
- Ischemic symptoms and angiographic diameter stenosis ≥ 50% by core laboratory QCA
- Angiographic diameter stenosis ≥ 70% by core laboratory QCA without angina or positive functional study
Measured: 5 years
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 1 month
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 6 months
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 1 year
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 2 years
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 3 years
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 4 years
Number of Participants Experiencing All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac Death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
Vascular Death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause.
Non-cardiovascular Death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Measured: 5 years
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 1 month
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 6 months
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 1 year
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 2 years
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 3 years
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 4 years
Number of Participants With All Myocardial Infarction ((MI: Q-wave Myocardial Infarction (Q-MI) or Non- Q-wave Myocardial Infarction (NQ-MI))
- Q wave MI: Development of new, pathological Q wave on the ECG.
-Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Measured: 5 years
Number of Participants With Target Vessel MI (TV-MI)
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Vessel MI (TV-MI)
Measured: 1 month
Number of Participants With Target Vessel MI (TV-MI)
Measured: 6 months
Number of Participants With Target Vessel MI (TV-MI)
Measured: 1 year
Number of Participants With Target Vessel MI (TV-MI)
Measured: 2 years
Number of Participants With Target Vessel MI (TV-MI)
Measured: 3 years
Number of Participants With Target Vessel MI (TV-MI)
Measured: 4 years
Number of Participants With Target Vessel MI (TV-MI)
Measured: 5 years
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Acute (≤ 1 day)
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Subacute (>1 - 30 days)
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Late (31 - 365 days)
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Very Late (366 - 730 days)
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Very Late (731 - 1095 days)
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Very Late (1096 - 1460 days)
Number of Participants With Stent/Scaffold Thrombosis
ITT population. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab.
Timings:
- Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation
- Subacute scaffold/stent thrombosis: >24 hours - 30 days post stent implantation
- Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation
- Very late scaffold/stent thrombosis: >1 year post stent implantation
Measured: Very Late (1461 - 1825 days)
In-segment Late Loss (Non-inferiority)
Measured: 13 months
Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Pre-Nitroglycerin (NTG)
Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.
Measured: 2 years
Nitrate Vaso-reactivity Analysis/ In-device Mean Lumen Diameter: Absolute Vaso Dilatation
Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.
Absolute Vaso dilatation = Post Nitroglycerin (NTG) - Pre Nitroglycerin (NTG)
Measured: 2 years
Nitrate Vaso-reactivity Analysis / In-device Mean Lumen Diameter : Post-Nitroglycerin (NTG)
Intracoronary nitrate injection was used for evaluating vaso-reactivity as it is routinely used during percutaneous coronary intervention (PCI) procedure.
Measured: 2 years
Number of Participants With Cardiac Death, All MI, ID-TLR (MACE)
Measured: 5 years
Number of Participants With Not Ischemia-driven TLR (NID-TLR)
Measured: 5 years
Number of Participants With Non-Target Vessel MI (NTV-MI)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takeshi Kimura, MD, Principal investigator, Kyoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844284
- Sponsor's protocol ID
- 12-301
- Acronym
- ABSORB JAPAN
- Status last verified
- Jul 2019
- First submitted
- 29 Apr 2013
- Last updated
- 8 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
PubMed 33893022Kozuma K, Tanabe K, Hamazaki Y, Okamura T, Ando J, Ikari Y, Nakagawa Y, Kusano H, Ediebah D, Kimura T; ABSORB Japan Investigators. Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent - A Randomized Comparison Through 5 Years in Japan. Circ J. 2020 Apr 24;84(5):733-741. doi: 10.1253/circj.CJ-19-1184. Epub 2020 Mar 26.
PubMed 32213737Onuma Y, Honda Y, Asano T, Shiomi H, Kozuma K, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Hanaoka KI, Tanabe K, Okada K, Kitahara H, Ono M, Kusano H, Rapoza R, Simonton C, Popma JJ, Stone GW, Fitzgerald PJ, Serruys PW, Kimura T. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years. JACC Cardiovasc Interv. 2020 Jan 13;13(1):116-127. doi: 10.1016/j.jcin.2019.09.047.
PubMed 31918929Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.
PubMed 31561250Okada K, Honda Y, Kitahara H, Otagiri K, Tanaka S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Kimura T; ABSORB Japan Investigators. Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):648-661. doi: 10.1016/j.jcin.2017.11.034.
PubMed 29622143Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.
PubMed 29089314Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
PubMed 26825231Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.
PubMed 26330419
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of AVJ-301 (Absorb™ BVS), the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions in Japanese Population
- ClinicalTrials.gov ID
- NCT01844284
- Acronym / sponsor ID
- ABSORB JAPAN / 12-301
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Keywords
- Absorb™ BVS, Angioplasty, Bioabsorbable, Bioreabsorbable, BVS, Coronary Artery Disease, Coronary Artery Endothelial Responsiveness, Coronary artery restenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 6 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, Randomized (2:1), active control, single-blind, non-inferiority, multicenter, Japanese Clinical Trial to evaluate the safety and effectiveness of Absorb™ BVS (AVJ-301) in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions in Japanese population by comparing to approved metallic drug eluting stent.
Detailed description
Absorb™ BVS is currently in development at Abbott Vascular. Not available for sale in the US or Japan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorb™ BVS | Experimental | Device: Absorb™ BVSSubjects receiving Absorb™ BVS |
| XIENCE PRIME®/XIENCE Xpedition™ | Active comparator | Device: XIENCE PRIME®/XIENCE Xpedition™Subjects receiving XIENCE PRIME®/XIENCE Xpedition™ |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be at least 20 years of age.
- Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
- Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia) suitable for elective percutaneous coronary intervention (PCI).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must be able to take dual antiplatelet therapy for up to 1 year following the index procedure and anticoagulants prior/during the index procedure. Therefore the subject has no known allergic reaction, hypersensitivity or contraindication to aspirin, clopidogrel, ticlopidine or heparin.
Key exclusion criteria (34 listed)
- Elective surgery is planned within 1 year after the procedure that will require general anesthesia or discontinuing either aspirin or Thienopyridine.
- Subject has known hypersensitivity or contraindication to device material and its degredants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated.
- Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
- Subject had an acute myocardial infarction (AMI) within 72 hours of the index procedure
- Subject has an unstable cardiac arrhythmia which is likely to become hemodynamically unstable due to arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XIENCE PRIME®/XIENCE Xpedition™Subjects receiving XIENCE PRIME®/XIENCE Xpedition™ | Device | XIENCE PRIME®/XIENCE Xpedition™ |
| Absorb™ BVSSubjects receiving Absorb™ BVS | Device | Absorb™ BVS |
Primary outcome
Number of Participants With Target Lesion Failure (TLF)
Time frame: 1 year
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
101 secondary outcomes
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 1 month
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 6 months
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 1 year
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 2 years
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 3 years
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 4 years
Number of Participants With Any Death/Any MI/Revascularization (DMR)
Time frame: 5 years
Number of Participants With Target Vessel Failure (TVF)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Vessel Failure (TVF)
Time frame: 1 month
Number of Participants With Target Vessel Failure (TVF)
Time frame: 6 months
Number of Participants With Target Vessel Failure (TVF)
Time frame: 1 year
Number of Participants With Target Vessel Failure (TVF)
Time frame: 2 years
Number of Participants With Target Vessel Failure (TVF)
Time frame: 3 years
Number of Participants With Target Vessel Failure (TVF)
Time frame: 4 years
Number of Participants With Target Vessel Failure (TVF)
Time frame: 5 years
Number of Participants With Target Lesion Failure (TLF)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Target Lesion Failure (TLF)
Time frame: 1 month
Number of Participants With Target Lesion Failure (TLF)
Time frame: 6 months
Number of Participants With Target Lesion Failure (TLF)
Time frame: 2 years
Number of Participants With Target Lesion Failure (TLF)
Time frame: 3 years
Number of Participants With Target Lesion Failure (TLF)
Time frame: 4 years
Number of Participants With Target Lesion Failure (TLF)
Time frame: 5 years
Number of Participants With Cardiac Death/All MI
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Cardiac Death/All MI
Time frame: 1 month
Number of Participants With Cardiac Death/All MI
Time frame: 6 months
Number of Participants With Cardiac Death/All MI
Time frame: 1 year
Number of Participants With Cardiac Death/All MI
Time frame: 2 years
Number of Participants With Cardiac Death/All MI
Time frame: 3 years
Number of Participants With Cardiac Death/All MI
Time frame: 4 years
Number of Participants With Cardiac Death/All MI
Time frame: 5 years
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 1 month
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 6 months
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 1 year
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 2 years
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 3 years
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 4 years
Number of Participants With All Target Vessel Revascularization (TVR)
Time frame: 5 years
Number of Participants With Ischemia-driven TVR (ID-TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33893022Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
- Derived from this study: PubMed 32213737Kozuma K, Tanabe K, Hamazaki Y, Okamura T, Ando J, Ikari Y, Nakagawa Y, Kusano H, Ediebah D, Kimura T; ABSORB Japan Investigators. Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent - A Randomized Comparison Through 5 Years in Japan. Circ J. 2020 Apr 24;84(5):733-741. doi: 10.1253/circj.CJ-19-1184. Epub 2020 Mar 26.
- Derived from this study: PubMed 31918929Onuma Y, Honda Y, Asano T, Shiomi H, Kozuma K, Ozaki Y, Namiki A, Yasuda S, Ueno T, Ando K, Furuya J, Hanaoka KI, Tanabe K, Okada K, Kitahara H, Ono M, Kusano H, Rapoza R, Simonton C, Popma JJ, Stone GW, Fitzgerald PJ, Serruys PW, Kimura T. Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years. JACC Cardiovasc Interv. 2020 Jan 13;13(1):116-127. doi: 10.1016/j.jcin.2019.09.047.
- Derived from this study: PubMed 31561250Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.
- Derived from this study: PubMed 29622143Okada K, Honda Y, Kitahara H, Otagiri K, Tanaka S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Kimura T; ABSORB Japan Investigators. Bioresorbable Scaffold for Treatment of Coronary Artery Lesions: Intravascular Ultrasound Results From the ABSORB Japan Trial. JACC Cardiovasc Interv. 2018 Apr 9;11(7):648-661. doi: 10.1016/j.jcin.2017.11.034.
- Derived from this study: PubMed 29089314Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.
- Derived from this study: PubMed 26825231Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
- Derived from this study: PubMed 26330419Kimura T, Kozuma K, Tanabe K, Nakamura S, Yamane M, Muramatsu T, Saito S, Yajima J, Hagiwara N, Mitsudo K, Popma JJ, Serruys PW, Onuma Y, Ying S, Cao S, Staehr P, Cheong WF, Kusano H, Stone GW; ABSORB Japan Investigators. A randomized trial evaluating everolimus-eluting Absorb bioresorbable scaffolds vs. everolimus-eluting metallic stents in patients with coronary artery disease: ABSORB Japan. Eur Heart J. 2015 Dec 14;36(47):3332-42. doi: 10.1093/eurheartj/ehv435. Epub 2015 Sep 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kimura, MD principal investigator
Kyoto University
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XIENCE PRIME®/XIENCE Xpedition™ and Absorb™ BVS in people with Coronary Artery Disease and Myocardial Ischemia, run by Abbott Medical Devices at 39 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Target Lesion Failure (TLF) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01844284, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.