ABSORB EXTEND Clinical Investigation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01023789
First received: November 30, 2009
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease
Device: ABSORB BVS

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • (This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure) [ Time Frame: Acute ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac Death (CD) [ Time Frame: 30, 180 days, and 1, 2, and 3 years. ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Myocardial Infarction (MI) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Target Vessel Myocardial Infarction (TV-MI) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia Driven MACE (ID MACE) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia driven Target Vessel Failure (ID TVF) [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia Driven Target Lesion Revascularization (ID TLR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Ischemia Driven Target Vessel Revascularization (ID TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Scaffold thrombosis [ Time Frame: 30, 180 days, and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • OCT: Descriptive analysis of strut, lesion and vessel morphology post-procedure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • OCT: Scaffold area post-procedure (if analyzable) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • OCT: Lumen area [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • OCT: Minimum luminal area (MLA) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • OCT: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition [ Time Frame: 2 years (if analyzable) ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site Late Loss (LL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated segment LL [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Vessel area [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Scaffold area (if analyzable) [ Time Frame: post-procedure and 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Minimum luminal area (MLA) [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Treated site %Volume Obstruction (VO) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • MSCT subgroup: Descriptive analysis of vascular and scaffold morphology [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition [ Time Frame: 2 years (if analyzable) ] [ Designated as safety issue: No ]
  • Ischemia driven Non-Target Vessel Revascularization (ID non- TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months

  • Lumen area [ Time Frame: post-procedure and at 2 years ] [ Designated as safety issue: No ]
  • Ischemia driven Non-Target Vessel Revascularization (ID non-TVR) [ Time Frame: 30, 180 days and 1, 2, and 3 years ] [ Designated as safety issue: Yes ]
    Subjects in the MSCT subgroup will also have clinical follow-up at 18 months


Estimated Enrollment: 807
Study Start Date: January 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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, LCX with obtuse marginal and/or ramus intermedius branches and 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023789

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

No publications provided by Abbott Vascular

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01023789     History of Changes
Other Study ID Numbers: 09-386, ACTRN12610000131055, REFCTRI000460, 03-05-2010
Study First Received: November 30, 2009
Last Updated: August 6, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Abbott Vascular:
Drug eluting stent
Stents
Angioplasty
Bioabsorbable
Bioresorbable
Scaffold

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014