Myocardial IschemiaABSORB EXTENDNCT01023789
ABSORB EXTEND Clinical Investigation
A study testing ABSORB BVS in people with Myocardial Ischemia and Coronary Artery Stenosis, run by Abbott Medical Devices at 56 sites in 25 countries.
Trial summary
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- What is being tested?
- ABSORB BVS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 56 sitesin 25 countries
- Study dates
- Jan 2010to Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
- Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
- Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
- If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
- Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
- Percutaneous intervention for lesions in the target vessel are allowed if done > 6 months prior to or if planned to be done 6 months after the index procedure.
Who cannot join
- Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
- Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
- Total occlusion (TIMI flow 0), prior to wire passing.
- Target vessel(s) contains visible thrombus.
- Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
- Subject has received brachytherapy in any epicardial vessel (including side branches).
Trial locations and contacts
56 sites in 25 countries.
56 sites in 25 countries
India8 sites
SAL Hospital And Medical Institute
Ahmedabad, 380054
Care Institute of Medical Sciences
Ahmedabad, 380060
Madras Medical Mission
Chennai, 600 037
Medanta -The Medicity
Gūrgaon, 122001
Apollo Hospital
Hyderabaad, Andhar Pradesh, 500033
CARE Hospital
Hyderabaad, Andhra Pradesh, 500034
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, 226014
Escorts Heart Institute & Research Centre
New Delhi, 110 070
Japan5 sites
Mitsui Memorial Hospital
Chiyoda-ku, 101-8643
Shonan Kamakura General Hospital
Kamakura, Kanagawa
Kyoto University Hospital
Kyoto, Kansai
Teikyo University
Tokyo, Itabashi
Saiseikai Yokohama City Eastern Hospital
Yokohama, Kanagawa
Australia4 sites
Wesley Hospital
Auchenflower, Queensland
St. Vincent's Hospital
Melbourne, Victoria, 3065
Monash Medical Center
Melbourne, Victoria, 3168
Eastern Heart Clinic, The Prince of Wales Hospital
Randwick, New South Wales, 2031
Canada4 sites
Montreal Heart Institute
Montreal, H1T 1C8
University of Ottawa Heart Institute
Ottawa, K1Y 4W7
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, G1V4G5
St. Michael's Hospital
Toronto, M5B 1W8
Brazil3 sites
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
São Paulo, 04012-180
Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
São Paulo, 05652-901
Instituto Coração Triângulo Mineiro
Uberlândia, 38400-368
France3 sites
Institut Jacques Cartier (ICPS)
Massy, 91300
Clinique Pasteur
Toulouse, 31076
Hopital De Rangueil - CHU
Toulouse, 31403
Netherlands3 sites
Catharina ZH Eindhoven
Eindhoven
Erasmus Medical Center
Rotterdam
Maasstad Ziekenhuis
Rotterdam
Spain3 sites
Clinico San Carlos
Madrid
La Paz
Madrid
Hospital do Meixoeiro
Pontevedra, 36200
Germany2 sites
Charité Berlin Campus Steglitz
Berlin, 12203
Uni.Klinikum Heidelberg
Heidelberg, 69115
Italy2 sites
Catanzaro University Hospital
Catanzaro, 88100
Centro Cardiologico Monzino
Milan
New Zealand2 sites
Mercy Angiography Unit
Auckland, 1023
Christchurch Hospital
Christchurch
Taiwan2 sites
Chang Gung Memorial Hospital
Kaohsiung City, 83301
National Taiwan University Hospital
Taipei
United Kingdom2 sites
Glenfield Hospital
Leicester
King's College Hospital
London
Argentina1 site
Instituto Cardiovascular de Buenos Aires-ICBA
Buenos Aires, 1428
About this study
Official title: ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System
ABSORB BVS is currently in development at Abbott Vascular.
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease
- Being tested
- ABSORB BVS
- Keywords
- Drug eluting stent, Stents, Angioplasty, Bioabsorbable, Bioresorbable, Scaffold
- Medical subject headings
- Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSORB BVSDevice
Absorb Bioresorbable Vascular Scaffold (BVS) System implantation
| Study group | Role | What they receive |
|---|---|---|
| ABSORB BVS | Experimental | Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease Receives: Device: ABSORB BVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
- Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Measured: ≤ 7 days post index procedure (In hospital)
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI),
- Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Measured: 0 to 30 days
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Measured: 0 to 180 days
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Measured: 0 to 1 year
Secondary outcomes (60)
Clinical Device Success
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis < 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met.
Measured: On day 0 (immediate post-index procedure)
Clinical Procedure Success
Defined as successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of < 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure. In a dual lesion setting both lesions must meet clinical procedure success.
Measured: On day 0 (immediate post-index procedure)
Number of Participants With 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 procedure related deaths including those related to concomitant treatment.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Q wave MI : Development of new, pathological Q wave on the ECG Non-Q wave MI : Elevation of creatine kinase (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 Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Measured: ≤ 7 days post index procedure (In-hospital )
Number of Participants With 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 procedure related deaths including those related to concomitant treatment.
Measured: 0 to 30 days
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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: 0 to 30 days
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 30 days
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 30 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Measured: 0 to 30 days
Number of Participants With 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 procedure related deaths including those related to concomitant treatment.
Measured: 0 to 180 days
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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: 0 to 180 days
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 180 days
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 180 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Measured: 0 to 180 days
Number of Participants With 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 procedure related deaths including those related to concomitant treatment.
Measured: 0 to 1 year
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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: 0 to 1 year
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 1 year
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 1 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Measured: 0 to 1 year
Number of Participants With 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 procedure related deaths including those related to concomitant treatment.
Measured: 0 to 2 year
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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: 0 to 2 year
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 2 year
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 2 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Measured: 0 to 2 year
Number of Participants With 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 procedure related deaths including those related to concomitant treatment.
Measured: 0 to 3 years
Number of Participants With Myocardial Infarction (MI) - Per Protocol
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: 0 to 3 years
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Revascularization at the target lesion associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target lesion with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 3 years
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Revascularization in the target vessel associated with any of the following:
- Positive functional ischemia study.
- Ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA).
- Revascularization of a target vessel with diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study.
Measured: 0 to 3 years
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Measured: 0 to 3 years
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: ≤ 7 days post index procedure (In hospital)
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 30 days
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 180 days
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 1 year
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 2 years
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
The composite endpoint composed of
- Cardiac death,
- Myocardial infarction (Q wave and Non-Q wave),
- Ischemia-driven target vessel revascularization by CABG or PCI.
Measured: 0 to 3 years
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Measured: 0 to 2 years
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Measured: 0 to 3 years
Number of Participants With Scaffold Thrombosis (Early)
According to the Academic Research Consortium (ARC) Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 0 to 30 days
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 0 to 180 days
Number of Participants With Scaffold Thrombosis (Late)
According to the ARC Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 31 - 365 days
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 0 to 1 year
Number of Participants With Scaffold Thrombosis (Very Late)
According to the ARC Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 366 days to 2 years
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 0 to 2 years
Number of Participants With Scaffold Thrombosis
According to the ARC Definition, 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.
Timing:
Acute stent thrombosis*: 0 - 24 hours post stent implantation Subacute stent thrombosis*: >24 hours - 30 days post stent implantation Late stent thrombosis†: 30 days - 1 year post stent implantation Very late stent thrombosis†: >1 year post stent implantation
*Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis (0 - 30 days).
†Including "primary" as well as "secondary" late stent thrombosis; "secondary" late stent thrombosis is a stent thrombosis after a target segment revascularization.
Measured: 0 to 3 years
Area Stenosis (%)
Measured: 18 months
Minimum Lumen Area
Measured: 18 months
Mean Vessel Area
Measured: 18 months
Minimum Vessel Area
Measured: 18 months
Maximum Vessel Area
Measured: 18 months
Mean Lumen Area
Measured: 18 months
Maximum Lumen Area
Measured: 18 months
Mean Plaque Area
Measured: 18 months
Minimum Plaque Area
Measured: 18 months
Maximum Plaque Area
Measured: 18 months
Mean Reference Area
Measured: 18 months
Calculated Minimum Lumen Diameter
The average of two orthogonal views (when possible) of the narrowest point within the area of assessment - treated lesion, treated site or treated segment. MLD is visually estimated during angiography by the Investigator; it is measured during QCA by the Angiographic Core Lab.
Measured: 18 months
Calculated Diameter Stenosis
The value calculated as 100 * (1 - Minimum Lumen Diameter (MLD) / reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2016
- Study completionOct 2016
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 (7)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies 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
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandre Abizaid, MD, Principal investigator, Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de AngioplastiaPatrick Serruys, MD, Study chair, Thoraxcenter-Erasmus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023789
- Sponsor's protocol ID
- 09-386
- Other IDs
- ACTRN12610000131055, REFCTRI000460, 03-05-2010
- Acronym
- ABSORB EXTEND
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2009
- Last updated
- 14 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.
PubMed 30286520Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051.
PubMed 29699614Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.
PubMed 26585622Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243.
PubMed 24769555Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
PubMed 24746650Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available.
PubMed 23866188Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.
PubMed 23517836
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABSORB EXTEND Clinical Investigation: A Continuation in the Clinical Evaluation of the ABSORB Bioresorbable Vascular Scaffold (BVS) System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT01023789
- Acronym / sponsor ID
- ABSORB EXTEND / 09-386
- Conditions
- Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Cardiovascular Disease
- Keywords
- Drug eluting stent, Stents, Angioplasty, Bioabsorbable, Bioresorbable, Scaffold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Dec 2009 (estimated)
- Results
- Posted 18 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System
ABSORB BVS is currently in development at Abbott Vascular.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSORB BVS | Experimental | Device: ABSORB BVSAbsorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Up to two de novo lesions can be treated, each located in a separate native epicardial vessel.
- Target lesion(s) must be located in a native coronary artery where target vessel(s) diameter is ≥ 2.0 mm and ≤ 3.3 mm and target lesion length is ≤ 28 mm, both assessed by on-line Quantitative Coronary Analysis (QCA).
- Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 1.
- If two treatable lesions meet the inclusion criteria they must be in separate major epicardial vessels (LAD with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
- Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥ 30 days prior to or if planned to be done 6 months after the index procedure.
Key exclusion criteria (6 listed)
- Lesion(s) located within an arterial or saphenous vein graft or distal to a diseased (defined as vessel irregularity per angiogram and > 20% stenosed lesion by visual estimation) arterial or saphenous vein graft.
- Lesion(s) involving a bifurcation with side branch vessel ≥ 2 mm in diameter and/or ostial lesion > 40% stenosed by visual estimation or side branch requiring predilatation.
- Total occlusion (TIMI flow 0), prior to wire passing.
- Target vessel(s) contains visible thrombus.
- Another clinically significant lesion is located in the same epicardial vessel (including side branch) as the target lesion(s).
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 |
|---|---|---|
| ABSORB BVSAbsorb Bioresorbable Vascular Scaffold (BVS) System implantation | Device | ABSORB BVS |
Primary outcome
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Time frame: ≤ 7 days post index procedure (In hospital)
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by Coronary artery bypass grafting (CABG) or Percutaneous Coronary Intervention (PCI).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Time frame: 0 to 30 days
The composite endpoint composed of * Cardiac death, * Myocardial infarction (MI, classified as Q-wave and Non-Q wave MI), * Ischemia-driven target lesion revascularization (TLR) by CABG or PCI.
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Time frame: 0 to 180 days
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Time frame: 0 to 1 year
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
60 secondary outcomes
Clinical Device Success
Time frame: On day 0 (immediate post-index procedure)
Clinical Procedure Success
Time frame: On day 0 (immediate post-index procedure)
Number of Participants With Cardiac Death
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: ≤ 7 days post index procedure (In-hospital )
Number of Participants With Cardiac Death
Time frame: 0 to 30 days
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Time frame: 0 to 30 days
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 0 to 30 days
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 30 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 30 days
Number of Participants With Cardiac Death
Time frame: 0 to 180 days
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Time frame: 0 to 180 days
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 0 to 180 days
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 180 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 180 days
Number of Participants With Cardiac Death
Time frame: 0 to 1 year
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Time frame: 0 to 1 year
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 0 to 1 year
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 1 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 1 year
Number of Participants With Cardiac Death
Time frame: 0 to 2 year
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Time frame: 0 to 2 year
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 0 to 2 year
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 2 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 2 year
Number of Participants With Cardiac Death
Time frame: 0 to 3 years
Number of Participants With Myocardial Infarction (MI) - Per Protocol
Time frame: 0 to 3 years
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)
Time frame: 0 to 3 years
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 3 years
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)
Time frame: 0 to 3 years
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Time frame: ≤ 7 days post index procedure (In hospital)
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Time frame: 0 to 30 days
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Time frame: 0 to 180 days
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Time frame: 0 to 1 year
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Time frame: 0 to 2 years
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)
Time frame: 0 to 3 years
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Time frame: 0 to 2 years
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)
Time frame: 0 to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30286520Costa JR Jr, Abizaid A, Whitbourn R, Serruys PW, Jepson N, Steinwender C, Stuteville M, Ediebah D, Sudhir K, Bartorelli AL; ABSORB EXTEND investigators. Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial. Catheter Cardiovasc Interv. 2019 Jan 1;93(1):E1-E7. doi: 10.1002/ccd.27715. Epub 2018 Oct 4.
- Derived from this study: PubMed 29699614Moriyama N, Shishido K, Tanaka Y, Yokota S, Hayashi T, Miyashita H, Koike T, Yokoyama H, Takada T, Nishimoto T, Ochiai T, Tobita K, Yamanaka F, Mizuno S, Murakami M, Takahashi S, Saito S. Neoatherosclerosis 5 Years After Bioresorbable Vascular Scaffold Implantation. J Am Coll Cardiol. 2018 May 1;71(17):1882-1893. doi: 10.1016/j.jacc.2018.02.051.
- Derived from this study: PubMed 26585622Ishibashi Y, Nakatani S, Sotomi Y, Suwannasom P, Grundeken MJ, Garcia-Garcia HM, Bartorelli AL, Whitbourn R, Chevalier B, Abizaid A, Ormiston JA, Rapoza RJ, Veldhof S, Onuma Y, Serruys PW. Relation Between Bioresorbable Scaffold Sizing Using QCA-Dmax and Clinical Outcomes at 1 Year in 1,232 Patients From 3 Study Cohorts (ABSORB Cohort B, ABSORB EXTEND, and ABSORB II). JACC Cardiovasc Interv. 2015 Nov;8(13):1715-26. doi: 10.1016/j.jcin.2015.07.026.
- Derived from this study: PubMed 24769555Abizaid A, Ribamar Costa J Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW; ABSORB EXTEND investigators. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. EuroIntervention. 2015 Apr;10(12):1396-401. doi: 10.4244/EIJV10I12A243.
- Derived from this study: PubMed 24746650Muramatsu T, Onuma Y, van Geuns RJ, Chevalier B, Patel TM, Seth A, Diletti R, Garcia-Garcia HM, Dorange CC, Veldhof S, Cheong WF, Ozaki Y, Whitbourn R, Bartorelli A, Stone GW, Abizaid A, Serruys PW; ABSORB Cohort B Investigators; ABSORB EXTEND Investigators; SPIRIT FIRST Investigators; SPIRIT II Investigators; SPIRIT III Investigators; SPIRIT IV Investigators. 1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials. JACC Cardiovasc Interv. 2014 May;7(5):482-93. doi: 10.1016/j.jcin.2014.01.155. Epub 2014 Apr 16.
- Derived from this study: PubMed 23866188Gogas BD, King SB 3rd, Timmins LH, Passerini T, Piccinelli M, Veneziani A, Kim S, Molony DS, Giddens DP, Serruys PW, Samady H. Biomechanical assessment of fully bioresorbable devices. JACC Cardiovasc Interv. 2013 Jul;6(7):760-1. doi: 10.1016/j.jcin.2013.04.008. No abstract available.
- Derived from this study: PubMed 23517836Muramatsu T, Onuma Y, Garcia-Garcia HM, Farooq V, Bourantas CV, Morel MA, Li X, Veldhof S, Bartorelli A, Whitbourn R, Abizaid A, Serruys PW; ABSORB-EXTEND Investigators. Incidence and short-term clinical outcomes of small side branch occlusion after implantation of an everolimus-eluting bioresorbable vascular scaffold: an interim report of 435 patients in the ABSORB-EXTEND single-arm trial in comparison with an everolimus-eluting metallic stent in the SPIRIT first and II trials. JACC Cardiovasc Interv. 2013 Mar;6(3):247-57. doi: 10.1016/j.jcin.2012.10.013.
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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.
Alexandre Abizaid, MD principal investigator
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
Patrick Serruys, MD study chair
Thoraxcenter-Erasmus University
56 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABSORB BVS in people with Myocardial Ischemia and Coronary Artery Stenosis, run by Abbott Medical Devices at 56 sites in 25 countries.
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 6 inclusion and 6 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 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in India, Japan, Australia, Canada, Brazil and 20 more countries. 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 18 Dec 2017). 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 Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR) (time frame: ≤ 7 days post index procedure (In hospital)). The study lists 4 primary outcomes in all. 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 NCT01023789, which also lists 7 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 14 Feb 2018.