ABSORB EXTEND Clinical Investigation

Not Applicable

Completed

Conditions: Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Cardiovascular Disease
Coronary Artery Stenosis
Coronary Restenosis

Interventions: Device: ABSORB BVS

Registration Number: NCT01023789

Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 812

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABSORB BVS	ABSORB BVS	Absorb Bioresorbable Vascular Scaffold (BVS) System implantation in the treatment of coronary artery disease

Primary Outcome Measures

Name	Time	Method
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	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).

Secondary Outcome Measures

Name	Time	Method
Mean Reference Area	18 months
Number of Participants With Ischemia Driven Target Lesion Revascularization (ID-TLR)	0 to 3 years	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.
Minimum Vessel Area	18 months
Maximum Lumen Area	18 months
Maximum Plaque Area	18 months
Number of Participants With Target Vessel Failure (TVF; Cardiac Death, Protocol MI, ID-TLR, ID-Non-TLR TVR)	0 to 3 years	The composite endpoint composed of * Cardiac death, * Myocardial infarction (Q wave and Non-Q wave), * Ischemia-driven target vessel revascularization by CABG or PCI.
Mean Lumen Area	18 months
Minimum Plaque Area	18 months
Number of Participants With Cardiac Death	0 to 3 years	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.
Number of Participants With Ischemic Driven Non-target Lesion Target Vessel Revascularization (ID-Non-TL TVR)	0 to 3 years
Number of Participants With Major Adverse Cardiac Events (MACE; Cardiac Death, Protocol MI, ID-TLR)	0 to 3 years	Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction and ischemia-driven target lesion revascularization (ID-TLR).
Maximum Vessel Area	18 months
Clinical Device Success	On day 0 (immediate post-index procedure)	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.
Clinical Procedure Success	On day 0 (immediate post-index procedure)	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.
Number of Participants With Scaffold Thrombosis (Early)	0 to 30 days	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.
Number of Participants With Scaffold Thrombosis (Late)	31 - 365 days	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.
Number of Participants With Scaffold Thrombosis (Very Late)	366 days to 2 years	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.
Area Stenosis (%)	18 months
Minimum Lumen Area	18 months
Mean Vessel Area	18 months
Mean Plaque Area	18 months
Number of Participants With Myocardial Infarction (MI) - Per Protocol	0 to 3 years	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
Number of Participants With Ischemia Driven Target Vessel Revascularization (ID-TVR)	0 to 3 years	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.
Number of Participants With Scaffold Thrombosis	0 to 3 years	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.
Calculated Minimum Lumen Diameter	18 months	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.
Calculated Diameter Stenosis	18 months	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).

Trial Locations

Locations (56): Onze-Lieve VrouweZiekenhuis
🇧🇪
Aalst, Belgium
Apollo Hospital
🇮🇳
Hyderabaad, Andhar Pradesh, India
SAL Hospital And Medical Institute
🇮🇳
Ahmedabad, India
Care Institute of Medical Sciences
🇮🇳
Ahmedabad, India
Escorts Heart Institute & Research Centre
🇮🇳
New Delhi, India
Kyoto University Hospital
🇯🇵
Kyoto, Kansai, Japan
Catharina ZH Eindhoven
🇳🇱
Eindhoven, Netherlands
Erasmus Medical Center
🇳🇱
Rotterdam, Netherlands
University Hospital Krakow
🇵🇱
Krakow, Poland
National University Hospital
🇸🇬
Singapore, Singapore
St. Michael's Hospital
🇨🇦
Toronto, Canada
Prince of Wales Hospital
🇨🇳
Hong Kong, China
Eastern Heart Clinic, The Prince of Wales Hospital
🇦🇺
Randwick, New South Wales, Australia
Wesley Hospital
🇦🇺
Auchenflower, Queensland, Australia
Sociedade Beneficente Isreaelita Brasileira Hospital Albert Einstein
🇧🇷
Sao Paulo, Brazil
Clinique Pasteur
🇫🇷
Toulouse, France
Hopital De Rangueil - CHU
🇫🇷
Toulouse, France
Instituto Cardiovascular de Buenos Aires-ICBA
🇦🇷
Buenos Aires, Argentina
CARE Hospital
🇮🇳
Hyderabaad, Andhra Pradesh, India
Madras Medical Mission
🇮🇳
Chennai, India
Medanta -The Medicity
🇮🇳
Gurgaon, India
Århus University Hospital
🇩🇰
Århus N, Denmark
Catanzaro University Hospital
🇮🇹
Catanzaro, Italy
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦
Quebec, Canada
Christchurch Hospital
🇳🇿
Christchurch, New Zealand
Allgemeines Krankenhaus Linz
🇦🇹
Linz, Austria
Mitsui Memorial Hospital
🇯🇵
Chiyoda-ku, Japan
Charité Berlin Campus Steglitz
🇩🇪
Berlin, Germany
Queen Mary Hospital
🇨🇳
Hong Kong, China
Centro Cardiologico Monzino
🇮🇹
Milano, Italy
La Paz
🇪🇸
Madrid, Spain
King's College Hospital
🇬🇧
London, United Kingdom
Uni.Klinikum Heidelberg
🇩🇪
Heidelberg, Germany
Mercy Angiography Unit
🇳🇿
Auckland, New Zealand
Rabin Medical Center
🇮🇱
Petah Tikva, Israel
Shonan Kamakura General Hospital
🇯🇵
Kamakura, Kanagawa, Japan
Inselspital Bern, Kardiologie
🇨🇭
Bern, Switzerland
Glenfield Hospital
🇬🇧
Leicester, United Kingdom
Clinico San Carlos
🇪🇸
Madrid, Spain
Sunninghill Hospital
🇿🇦
Johannesburg, South Africa
National Taiwan University Hospital
🇨🇳
Taipei, Taiwan
Monash Medical Center
🇦🇺
Melbourne, Victoria, Australia
St. Vincent's Hospital
🇦🇺
Melbourne, Victoria, Australia
Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia
🇧🇷
Sao Paulo, Brazil
Instituto Coração Triângulo Mineiro
🇧🇷
Uberlandia, Brazil
Montreal Heart Institute
🇨🇦
Montreal, Canada
University of Ottawa Heart Institute
🇨🇦
Ottawa, Canada
Institut Jacques Cartier (ICPS)
🇫🇷
Massy, France
Sanjay Gandhi Postgraduate Institute of Medical Sciences
🇮🇳
Lucknow, India
Saiseikai Yokohama City Eastern Hospital
🇯🇵
Yokohama, Kanagawa, Japan
Teikyo University
🇯🇵
Tokyo, Itabashi, Japan
Institute Jantung Negara
🇲🇾
Kuala Lumpur, Malaysia
Maasstad Ziekenhuis
🇳🇱
Rotterdam, Netherlands
Chang Gung Memorial Hospital
🇨🇳
Kaohsiung, Taiwan
Lund University Hospital
🇸🇪
Lund, Sweden
Hospital do Meixoeiro
🇪🇸
Pontevedra, Spain