REFCTRI/2010/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Mon, 23 Apr :30:46 GMT) CTRI Number CTRI/2010/091/ [Registered on: 15/10/2010] - Last Modified On 17/04/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Medical Device Surgical/Anesthesia Single Arm Trial Study of implantation of Abbott Vasculars Bioresorbable Vascular Scaffold in the treatment of coronary artery disease A Continuation of the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Protocol Number ACTRN NCT ANZCTR ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Source of Monetary or Material Support > Abbott Cardiovascular Systems, Inc./Abbott Vascular International, BVBA Primary Sponsor Details Abbott Cardiovascular Systems Inc 3200 Lakeside Dr. Santa Clara, Ca Clara, California USA Abbott Vascular International, BVBAPark LaneCulliganlaan 2B1831 Diegem Belgium Type of Sponsor NIL List of Countries of Principal Investigator Other [Medical Device Manufacturing Global] of Site Site Phone// Mathew Kalarickal Apollo Hospital, Chennai TAMIL NADU Mohammad Shariff CARE Hospital, Hyderabad ANDHRA PRADESH Dr Keyur Parikh Ashok Seth Ajit Mullasari, MD CTRI: Care Institute of Escorts Heart Institute and Research Center Madras Medical Mission Nr. Shukan Mall, Off Science City Road, Sola Ahmadabad GUJARAT Okhla Road, New Delhi DELHI 4-A, Dr. JJ Nagar,Moga pper Chennai TAMIL NADU Dr Praveen Chandra Medanta Medicity Sector 38 South West DELHI Yesha Mehta SAL Hospital OPP. DOORDARSHAN, DRIVE-IN ROAD, Ahmadabad GUJARAT Pravin Goel, MD Sanjay Gandhi Post Graduate Institute of Raebareli Road, Lucknow UTTAR PRADESH mdshariff_123@yahoo. co.in keyur.parikh@cims.me (044) info@medanta.org yesha008@gmail.com +91 (522) of Committee Approval Status Date of Approval Is Independent Ethics Committee? Apollo Hospitals Approved 27/12/2010 No CARE Foundation Approved 11/07/2011 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Institutional EC Care Institute of Approved 16/03/2011 No Escorts Approved 04/09/2010 No Madras Medical Mission Approved 21/07/2010 No Medanta Medicity Approved 22/11/2010 No SAL Approved 31/07/2010 No Sanjay Gandhi Approved 15/11/2010 No Postgraduate Institute of EC Status Date Approved/Obtained 18/07/2011 Health Type Patients Condition Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease Type Details Intervention Everolimus-Eluting Bioresorbable Vascular Scaffold (BVS) Comparator Agent NIL NIL Age From Age To Gender Details Details Inclusion Criteria Implantation of the device in the treatment of coronary artery disease 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 greater than 20% stenosed lesion by visual estimation) arterial or saphenous vein graft. Lesion(s) involving a bifurcation with side branch vessel greaterthan or equal to 2 mm in diameter and/or ostial lesion greater than 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). page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Not Applicable Not Applicable Open Label Subject has received brachytherapy in any epicardial vessel (including side branches). Primary Outcome Outcome Timepoints This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure) Acute Secondary Outcome Outcome Timepoints Cardiac Death (CD) Myocardial Infarction (MI) Target Vessel Myocardial Infarction (TV-MI) Ischemia Driven MACE (ID MACE) Ischemia driven Target Vessel Failure (ID TVF) Ischemia Driven Target Lesion Revascularization (ID TLR) Ischemia Driven Target Vessel Revascularization (ID TVR) Scaffold thrombosis OCT: Descriptive analysis of strut, lesion and vessel morphology post-procedure OCT: Scaffold area post-procedure (if analyzable) OCT: Lumen area OCT: Minimum luminal area (MLA) OCT: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition Angiographic OCT subgroup: Treated site Late Loss (LL) Angiographic OCT subgroup: Treated segment LL Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement). (if analyzable) Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement) Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD) Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS) Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rate Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissection IVUS OCT subgroup: Vessel area page 4 / 5

5 Powered by TCPDF ( REFCTRI/2010/ Target Sample Size IVUS OCT subgroup: Scaffold area (if analyzable) IVUS OCT subgroup: Minimum luminal area (MLA) IVUS OCT subgroup: Treated site %Volume Obstruction (VO) MSCT subgroup: Descriptive analysis of vascular and scaffold morphology IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition Ischemia driven Non-Target Vessel Revascularization (ID non- TVR) Lumen area Total Sample Size=1000 Sample Size from =150 Phase of Trial Phase 3/ Phase 4 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified 01/01/2010 Years=3 Months=0 Days=0 Open to Recruitment Open to Recruitment NIL at this time post-procedure and 18 months (if analyzable) ABSORB EXTEND Clinical Investigation: This trial is a continuation in the Clinical Evaluation of the Abbott Vascular Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions. The Primary Investigator and study Chair for this study are: Alexandre Abizaid, MD Study Principal Investigator Instituto de Cardiologia Dante Pazzanese Unidadae II Recepcao de Angioplastia. Brazil Patrick Serruys, MD Study Chair Thoraxcenter-Erasmus University Netherlands This is a global trial and began international recruitment in January of Recruitment in has not yet begun. Recruitment of 1000 participants worldwide is expected. Approximately 105 patients overall will be enrolled in, equating to approximately 15 patients at each site. page 5 / 5