ABSORB EXTEND Clinical Investigation (ABSORB EXTEND)

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Disease; Cardiovascular Disease; Coronary Restenosis; Coronary Artery Stenosis
• Intervention / Treatment: Device: ABSORB BVS

• Study Type: Interventional
• Enrollment (Actual): 812
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1428
    • Instituto Cardiovascular de Buenos Aires-ICBA
• Australia
  • New South Wales
    • Randwick, New South Wales, Australia, 2031
      • Eastern Heart Clinic, The Prince of Wales Hospital
  • Queensland
    • Auchenflower, Queensland, Australia
      • Wesley Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3065
      • St. Vincent's Hospital
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Center
• Austria
  • Linz, Austria, 4020
    • Allgemeines Krankenhaus Linz
• Belgium
  • Aalst, Belgium
    • Onze-Lieve VrouweZiekenhuis
• Brazil
  • Sao Paulo, Brazil, 04012-180
    • Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
  • Sao Paulo, Brazil, 05652-901
    • Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
  • Uberlandia, Brazil, 38400-368
    • Instituto Coração Triângulo Mineiro
• Canada
  • Montreal, Canada, H1T 1C8
    • Montreal Heart Institute
  • Ottawa, Canada, K1Y 4W7
    • University of Ottawa Heart Institute
  • Quebec, Canada, G1V4G5
    • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
  • Toronto, Canada, M5B 1W8
    • St. Michael's Hospital
• China
  • Hong Kong, China
    • Prince of Wales Hospital
  • Hong Kong, China
    • Queen Mary Hospital
• Denmark
  • Århus N, Denmark, 8200
    • Århus University Hospital
• France
  • Massy, France, 91300
    • Institut Jacques Cartier (ICPS)
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France, 31403
    • Hôpital de Rangueil - CHU
• Germany
  • Berlin, Germany, 12203
    • Charité Berlin Campus Steglitz
  • Heidelberg, Germany, 69115
    • Uni.Klinikum Heidelberg
• India
  • Ahmedabad, India, 380054
    • Sal Hospital and Medical Institute
  • Ahmedabad, India, 380060
    • Care Institute of Medical Sciences
  • Chennai, India, 600 037
    • Madras Medical Mission
  • Gurgaon, India, 122001
    • Medanta -The Medicity
  • Lucknow, India, 226014
    • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • New Delhi, India, 110 070
    • Escorts Heart Institute & Research Centre
  • Andhar Pradesh
    • Hyderabaad, Andhar Pradesh, India, 500033
      • Apollo Hospital
  • Andhra Pradesh
    • Hyderabaad, Andhra Pradesh, India, 500034
      • Care Hospital
• Israel
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
• Italy
  • Catanzaro, Italy, 88100
    • Catanzaro University Hospital
  • Milano, Italy
    • Centro Cardiologico Monzino
• Japan
  • Chiyoda-ku, Japan, 101-8643
    • Mitsui Memorial Hospital
  • Itabashi
    • Tokyo, Itabashi, Japan
      • Teikyo University
  • Kanagawa
    • Kamakura, Kanagawa, Japan
      • Shonan Kamakura General Hospital
    • Yokohama, Kanagawa, Japan
      • Saiseikai Yokohama City Eastern Hospital
  • Kansai
    • Kyoto, Kansai, Japan
      • Kyoto University Hospital
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institute Jantung Negara
• Netherlands
  • Eindhoven, Netherlands
    • Catharina ZH Eindhoven
  • Rotterdam, Netherlands
    • Maasstad Ziekenhuis
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• New Zealand
  • Auckland, New Zealand, 1023
    • Mercy Angiography Unit
  • Christchurch, New Zealand
    • Christchurch Hospital
• Poland
  • Krakow, Poland, 31-501
    • University Hospital Krakow
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
• South Africa
  • Johannesburg, South Africa
    • Sunninghill Hospital
• Spain
  • Madrid, Spain
    • Clinico San Carlos
  • Madrid, Spain
    • La Paz
  • Pontevedra, Spain, 36200
    • Hospital Do Meixoeiro
• Sweden
  • Lund, Sweden, 221 85
    • Lund University Hospital
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern, Kardiologie
• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Chang Gung Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
• United Kingdom
  • Leicester, United Kingdom
    • Glenfield Hospital
  • London, United Kingdom
    • King's College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABSORB BVS; Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease	Device: ABSORB BVS; Absorb Bioresorbable Vascular Scaffold (BVS) System implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	≤ 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.	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).	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).	0 to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	≤ 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	≤ 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.	≤ 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.	≤ 7 days post index procedure (In-hospital )
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		≤ 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.	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	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.	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.	0 to 30 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		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.	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	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.	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.	0 to 180 days
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		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.	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	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.	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.	0 to 1 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		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.	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	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.	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.	0 to 2 year
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		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.	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	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.	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.	0 to 3 years
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)		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.	≤ 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.	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.	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.	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.	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.	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).	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).	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.	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.	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.	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.	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.	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.	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.	0 to 3 years
Area Stenosis (%)		18 months
Minimum Lumen Area		18 months
Mean Vessel Area		18 months
Minimum Vessel Area		18 months
Maximum Vessel Area		18 months
Mean Lumen Area		18 months
Maximum Lumen Area		18 months
Mean Plaque Area		18 months
Minimum Plaque Area		18 months
Maximum Plaque Area		18 months
Mean Reference Area		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.	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).	18 months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Alexandre Abizaid, MD, Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia; Study Chair: Patrick Serruys, MD, Thoraxcenter-Erasmus University

Publications and helpful links

General Publications

• Muramatsu 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.
• 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.
• Moriyama 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.
• Ishibashi 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.
• Abizaid 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.
• Gogas 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.
• Muramatsu 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: November 30, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Stents; Drug eluting stent; Angioplasty; Bioabsorbable; Bioresorbable; Scaffold
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Ischemia; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: 09-386; ACTRN12610000131055 (Registry Identifier: Australian New Zealand Clinical Trials Registry); REFCTRI000460, 03-05-2010 (Registry Identifier: Clinical Trials Registry - India)