Vascular DiseaseSV JAPANNCT01115933
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
A study testing XIENCE PRIME SV EECSS in people with Vascular Disease and Myocardial Ischemia, run by Abbott Medical Devices at 14 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- What is being tested?
- XIENCE PRIME SV EECSS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 14 sitesJapan
- Study dates
- Apr 2010to Dec 2013
- 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, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must agree to undergo all protocol-required follow-up procedures.
- Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
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- Angiographic Inclusion Criteria
- One (target) or two (one target and one non-target) de novo lesions each in a different epicardial vessel.
- Lesion(s) must be located in a major artery or branch with a visually estimated diameter stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
- Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.25 mm and < 2.5 mm.
- Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 22 mm.
Who cannot join
- Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
- The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
- Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
- Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Subject has received coronary brachytherapy in any epicardial vessel.
- Subject has received any organ transplant or is on a waiting list for any organ transplant.
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- Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or within one year after the index procedure.
- Subject is receiving or scheduled to receive planned radiotherapy to the chest/mediastinum.
- Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.).
- Subject is receiving chronic anticoagulation therapy (e.g., heparin, warfarin).
- Subject will require Low Molecular Weight Heparin (LMWH) post-procedure.
- Subject has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, everolimus, cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
- Elective surgery is planned within 6 months after the procedure that will require discontinuing either aspirin or clopidogrel.
- Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a white blood cell (WBC) of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
- Subject has known renal insufficiency (examples being but not limited to serum creatinine level ≥ 2.0 mg/dL, or on dialysis).
- Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Subject has had a cerebrovascular accident/stroke or transient ischemic neurological attack (TIA) within the past six months.
- Subject has had a significant gastro-intestinal or significant urinary bleed within the past six months.
- Subject has extensive peripheral vascular disease that precludes safe 5 French catheter insertion.
- Subject has other medical illness (e.g., cancer) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year).
- Subject is currently participating in another clinical study that has not yet completed its primary endpoint.
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test*.
- Whether a subject who met this criterion will be asked for pregnancy test will be decided per site standard. However, subject enrollment in the study is not allowed without pregnancy test result.
- Angiographic Exclusion Criteria All angiographic exclusion criteria are based on visual estimation.
- Target lesion located within an arterial or saphenous vein graft or distal to a diseased (vessel irregularity per angiogram and > 20% stenosed lesion) arterial or saphenous vein graft.
- Target lesion involving a bifurcation with a side branch ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed or side branch requiring protection guidewire, or side branch requiring dilatation.
- Target lesion with total occlusion (TIMI flow 0), prior to crossing with the wire.
- Another lesion requiring revascularization is located in the same epicardial vessel of the target lesion.
- Restenotic lesion.
- Aorto-ostial target lesion (within 3 mm of the aorta junction).
- Lesion in the left main trunk (both target and non-target).
- Lesion located within 2 mm of the origin of the LAD or LCX.
- Extreme angulation (≥ 90 °) or excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
- Heavy calcification proximal to or within the target lesion.
- Target vessel contains thrombus as indicated in the angiographic images.
- Target lesion has a high probability that a procedure other than pre-dilatation and stenting will be required at the time of index procedure for treatment of the target vessel (e.g. rotablator, DCA, cutting balloon).
- Target vessel is previously treated* with any type of PCI (e.g. balloon angioplasty, stent, rotablator, DCA, cutting balloon) within 9 months of index procedure.
- Non-target vessel was previously treated with any type of PCI within 90 days of index procedure.
- Additional clinically significant lesion(s) in the target vessel or side branch for which PCI may be required within 90 days after the index procedure.
- Target lesion must be separated ≥ 5 mm from a previously treated lesion (stenosis within 5 mm of previously treated lesion is regarded as "restenosis").
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Tokai University Hospital
Isehara, Kanagawa
Shonan Kamakura General Hospital
Kamakura, Kanagawa
Sakurabashi Watanabe Hospital
Kita-ku, Osaka
Kokura Memorial Hospital
Kitakyushu, Fukuoka
Tokushima Red Cross Hospital
Komatsushimachō, Tokushima
Kumamoto Central Hospital
Kumamoto, Kumamoto
Kurashiki Central Hospital
Kurashiki, Okayama-ken
Kyoto University Hospital
Sakyo-ku, Kyoto
Sendai Kousei Hospital
Sendai, Miyagi
Nagoya Daini Red Cross Hospital
Shōwaku, Nagoya
Osaka University Hospital
Suita, Osaka
Teikyo University
Tokyo, Itabashi
Hokkaido Social Insurance Hospital Cardiovascular Center
Toyohira, Hokkaido
Saiseikai Yokohama City Eastern Hospital
Yokohama, Kanagawa
About this study
Official title: SPIRIT PRIME JAPAN (SV JAPAN)
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Being tested
- XIENCE PRIME SV EECSS
- Keywords
- drug eluting stents, small vessel, Stents, Everolimus, Angioplasty
- Medical subject headings
- Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE PRIME SV EECSSDevice
Patients receiving XIENCE PRIME SV EECSS
| Study group | Role | What they receive |
|---|---|---|
| XIENCE PRIME SV EECSS | Experimental | XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System Receives: Device: XIENCE PRIME SV EECSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)
Measured: 9 Months
Secondary outcomes (39)
Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)
Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.
Measured: The period during an in-hospital stay of less than or equal to 7 days post index procedure.
Procedural Success(Subject Base Analysis)
Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.
Measured: The period during an in-hospital stay of less than or equal to 7 days post index procedure.
Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal
IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement
Measured: 8 months
Late Loss (LL), In-segment, In-stent, Proximal and Distal
LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:
In-segment Late Loss: in-segment MLD post-procedure - in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure - in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)
Measured: 8 months
Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal
IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.
PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement
Measured: 8 months
Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)
DEATH (Per ARC Circulation 2007; 115: 2344-2351)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Measured: 1 month
Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)
DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.
Measured: 9 months
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)
Definitions in SPIRIT III Study:
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 Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Measured: 1 month
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)
Definitions in SPIRIT III Study:
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 Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Measured: 9 months
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)
Definitions in SPIRIT III Study:
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
Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Measured: 1 month
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)
Definitions in SPIRIT III Study:
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 Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Measured: 9 months
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)
Definitions in SPIRIT III Study:
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 Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Measured: 1 month
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)
Definitions in SPIRIT III Study:
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 Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351
Measured: 9 months
Target Lesion Revascularization (TLR, Per ARC Definition)
Any revascularization for in-segment restenosis will be considered TLR."Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 1 month
Target Lesion Revascularization (TLR, Per ARC Definition)
Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 9 months
Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)
Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 1 month
Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)
Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 9 months
Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)
Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 1 month
Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)
Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 9 months
Target Vessel Revascularization (TVR, Per ARC Definition)
TVR 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. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 1 month
Target Vessel Revascularization (TVR, Per ARC Definition)
TVR 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. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 9 months
Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)
TVR 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. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 1 month
Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)
TVR 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. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 9 months
Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)
TVR 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. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 1 month
Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)
TVR 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. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.
Measured: 9 months
Composite Endpoint of Cardiac Death/All MI
Measured: 1 month
Composite Endpoint of Cardiac Death/All MI
Measured: 9 months
Composite Endpoint of All Death/All MI/All Revascularization (DMR)
DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).
Measured: 1 month
Composite Endpoint of All Death/All MI/All Revascularization (DMR)
DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).
Measured: 9 months
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 1 month
Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 1 month
Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).
Measured: 9 months
All Coronary Revascularization
Measured: 1 months
All Coronary Revascularization
Measured: 9 months
Acute Stent Thrombosis
Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Measured: <24 hours
Subacute Stent Thrombosis
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Measured: 1-30 days
Acute/Subacute Stent Thrombosis
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Measured: 0-30 days
Late Stent Thrombosis
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Measured: 31 - 298 days
Overall Stent Thrombosis
Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."
Measured: 0 - 298 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionDec 2013
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.
- Other trials for Vascular 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Takaaki Isshiki, MD, Principal investigator, Teikyo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115933
- Sponsor's protocol ID
- 09-385
- Acronym
- SV JAPAN
- Status last verified
- Jun 2015
- First submitted
- 5 Apr 2010
- Last updated
- 13 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIRIT PRIME JAPAN (SV JAPAN)
- ClinicalTrials.gov ID
- NCT01115933
- Acronym / sponsor ID
- SV JAPAN / 09-385
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Keywords
- drug eluting stents, small vessel, Stents, Everolimus, Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Posted 3 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease caused by de novo lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE PRIME SV EECSS | Experimental | Device: XIENCE PRIME SV EECSSXIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 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, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
- Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
- Subject must agree to undergo all protocol-required follow-up procedures.
Key exclusion criteria (40 listed)
- Subject has had a known diagnosis of acute myocardial infarction (AMI) preceding the index procedure (CK-MB ≥ 2 times upper limit of normal) and CK and CK-MB have not returned to within normal limits at the time of procedure.
- The subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
- Subject has current unstable cardiac arrhythmias associated with hemodynamic instability.
- Subject has a known left ventricular ejection fraction (LVEF) < 40% (LVEF may be obtained at the time of the index procedure if the value is unknown and if necessary).
- Subject has received coronary brachytherapy in any epicardial vessel.
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 SV EECSSPatients receiving XIENCE PRIME SV EECSS | Device | XIENCE PRIME SV EECSS |
Primary outcome
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
Time frame: 9 Months
Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)
39 secondary outcomes
Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)
Time frame: The period during an in-hospital stay of less than or equal to 7 days post index procedure.
Procedural Success(Subject Base Analysis)
Time frame: The period during an in-hospital stay of less than or equal to 7 days post index procedure.
Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal
Time frame: 8 months
Late Loss (LL), In-segment, In-stent, Proximal and Distal
Time frame: 8 months
Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal
Time frame: 8 months
Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)
Time frame: 1 month
Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)
Time frame: 9 months
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)
Time frame: 1 month
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)
Time frame: 9 months
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)
Time frame: 1 month
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)
Time frame: 9 months
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)
Time frame: 1 month
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)
Time frame: 9 months
Target Lesion Revascularization (TLR, Per ARC Definition)
Time frame: 1 month
Target Lesion Revascularization (TLR, Per ARC Definition)
Time frame: 9 months
Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)
Time frame: 1 month
Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)
Time frame: 9 months
Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)
Time frame: 1 month
Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)
Time frame: 9 months
Target Vessel Revascularization (TVR, Per ARC Definition)
Time frame: 1 month
Target Vessel Revascularization (TVR, Per ARC Definition)
Time frame: 9 months
Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)
Time frame: 1 month
Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)
Time frame: 9 months
Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)
Time frame: 1 month
Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)
Time frame: 9 months
Composite Endpoint of Cardiac Death/All MI
Time frame: 1 month
Composite Endpoint of Cardiac Death/All MI
Time frame: 9 months
Composite Endpoint of All Death/All MI/All Revascularization (DMR)
Time frame: 1 month
Composite Endpoint of All Death/All MI/All Revascularization (DMR)
Time frame: 9 months
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)
Time frame: 1 month
Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)
Time frame: 1 month
Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)
Time frame: 9 months
All Coronary Revascularization
Time frame: 1 months
All Coronary Revascularization
Time frame: 9 months
Acute Stent Thrombosis
Time frame: <24 hours
Subacute Stent Thrombosis
Time frame: 1-30 days
Acute/Subacute Stent Thrombosis
Time frame: 0-30 days
Late Stent Thrombosis
Time frame: 31 - 298 days
Overall Stent Thrombosis
Time frame: 0 - 298 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Takaaki Isshiki, MD principal investigator
Teikyo University Hospital
14 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 SV EECSS in people with Vascular Disease and Myocardial Ischemia, run by Abbott Medical Devices at 14 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 11 inclusion and 40 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 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 3 Jan 2014). 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?
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF) (time frame: 9 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2015.