| CTRI Number |
CTRI/2010/091/000460 [Registered on: 15/10/2010] |
| Last Modified On: |
17/04/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
Study of implantation of Abbott Vasculars Bioresorbable Vascular Scaffold in the treatment of coronary artery disease |
Scientific Title of Study
Modification(s)
|
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 |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 09-386 |
Protocol Number |
| ACTRN12610000131055 |
ANZCTR |
| NCT01023789 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Vikram Kukkadi |
| Designation |
Abbott Vascular Devices, India |
| Affiliation |
Abbott Vascular Devices, India |
| Address |
TKS Plaza, # 665/10
11-B Main Road, 5th block
Bangalore
KARNATAKA
560041
India |
| Phone |
91-80-411-46363 |
| Fax |
|
| Email |
vikram.kukkadi@av.abbott.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Vikram Kukkadi |
| Designation |
Abbott Vascular Devices, India |
| Affiliation |
Abbott Vascular Devices, India |
| Address |
TKS Plaza, # 665/10
11-B Main Road, 5th block
Bangalore
KARNATAKA
560041
India |
| Phone |
91-80-411-46363 |
| Fax |
|
| Email |
vikram.kukkadi@av.abbott.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Vikram Kukkadi |
| Designation |
Abbott Vascular Devices, India |
| Affiliation |
Abbott Vascular Devices, India |
| Address |
TKS Plaza, # 665/10
11-B Main Road, 5th block
Bangalore
KARNATAKA
560041
India |
| Phone |
91-80-411-46363 |
| Fax |
|
| Email |
vikram.kukkadi@av.abbott.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Abbott Cardiovascular Systems, Inc./Abbott Vascular International, BVBA |
|
Primary Sponsor
Modification(s)
|
| Name |
Abbott Cardiovascular Systems Inc |
| Address |
3200 Lakeside Dr.
Santa Clara, Ca. 95054
Clara, California 95054 USA
Abbott Vascular International, BVBAPark LaneCulliganlaan 2B1831 Diegem Belgium |
| Type of Sponsor |
Other [Medical Device Manufacturing Global] |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mathew Kalarickal |
Apollo Hospital |
,-600006
Chennai
TAMIL NADU |
91-11-47135000
|
| Mohammad Shariff |
CARE Hospital |
,-500034
Hyderabad
ANDHRA PRADESH |
+ 91-40-23607777
+ 91-40-23608050
mdshariff_123@yahoo.co.in |
| Dr Keyur Parikh |
CTRI: Care Institute of Medical Sciences |
Nr. Shukan Mall, Off Science City Road, Sola
Ahmadabad
GUJARAT |
91-9825066668
keyur.parikh@cims.me |
| Ashok Seth |
Escorts Heart Institute and Research Center |
Okhla Road,-110 025
New Delhi
DELHI |
91-11-47135000
|
| Ajit Mullasari , MD |
Madras Medical Mission |
4-A, Dr. JJ Nagar,Mogapper-600037
Chennai
TAMIL NADU |
(044) 26561801
|
| Dr Praveen Chandra |
Medanta Medicity |
Sector 38
South West
DELHI |
911244141414
info@medanta.org |
| Yesha Mehta |
SAL Hospital |
OPP. DOORDARSHAN, DRIVE-IN ROAD,-380054
Ahmadabad
GUJARAT |
+91 79 26845600
yesha008@gmail.com |
| Pravin Goel, MD |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Raebareli Road ,-226 014
Lucknow
UTTAR PRADESH |
+91 (522) 2668004
|
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Apollo Hospitals |
Approved |
| CARE Foundation Institutional EC |
Approved |
| Care Institute of Medical Sciences |
Approved |
| Escorts |
Approved |
| Madras Medical Mission |
Approved |
| Medanta Medicity |
Approved |
| SAL |
Approved |
| Sanjay Gandhi Postgraduate Institute of Medical Sciences EC |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Everolimus-Eluting Bioresorbable Vascular Scaffold (BVS) |
Implantation of the device in the treatment of coronary artery disease |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
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. |
|
| ExclusionCriteria |
| Details |
•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).
•Subject has received brachytherapy in any epicardial vessel (including side branches). |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| This trial has no primary outcome, all outcomes are of equal weight) Acute success (clinical device and clinical procedure) |
Acute |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Cardiac Death (CD) |
30, 180 days, and 1, 2, and 3 years. |
| Myocardial Infarction (MI) |
30, 180 days, and 1, 2, and 3 years |
| Target Vessel Myocardial Infarction (TV-MI) |
30, 180 days, and 1, 2, and 3 years |
| Ischemia Driven MACE (ID MACE) |
30, 180 days, and 1, 2, and 3 years |
| Ischemia driven Target Vessel Failure (ID TVF) |
30, 180 days, and 1, 2, and 3 years |
| Ischemia Driven Target Lesion Revascularization (ID TLR) |
30, 180 days and 1, 2, and 3 years |
| Ischemia Driven Target Vessel Revascularization (ID TVR) |
30, 180 days and 1, 2, and 3 years |
| Scaffold thrombosis |
30, 180 days, and 1, 2, and 3 years |
| OCT: Descriptive analysis of strut, lesion and vessel morphology post-procedure |
2 years |
| OCT: Scaffold area post-procedure (if analyzable) |
2 years |
| OCT: Lumen area |
post-procedure and at 2 years |
| OCT: Minimum luminal area (MLA) |
post-procedure and at 2 years |
| OCT: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition |
2 years (if analyzable) |
| Angiographic OCT subgroup: Treated site Late Loss (LL) |
2 years |
| Angiographic OCT subgroup: Treated segment LL |
2 years |
| Angiographic OCT subgroup: Proximal LL (proximal defined as within 5 mm of tissue proximal to scaffold placement) |
2 years |
| Angiographic OCT subgroup: Distal LL (distal defined as within 5 mm of tissue distal to scaffold placement) |
2 years |
| Angiographic OCT subgroup: Treated site and treated segment Minimum Luminal Diameter (MLD) |
post-procedure and at 2 years |
| Angiographic OCT subgroup: Treated site and treated segment % Diameter Stenosis (DS) |
post-procedure and at 2 years |
| Angiographic OCT subgroup: Treated site and treated segment Angiographic Binary Restenosis (ABR) rate |
2 years |
| Angiographic OCT subgroup: Aneurysm, thrombus, persisting dissection |
2 years |
| IVUS OCT subgroup: Vessel area |
post-procedure and at 2 years |
| IVUS OCT subgroup: Scaffold area (if analyzable) |
post-procedure and 2 years |
| IVUS OCT subgroup: Minimum luminal area (MLA) |
post-procedure and at 2 years |
| IVUS OCT subgroup: Treated site %Volume Obstruction (VO) |
2 years |
| MSCT subgroup: Descriptive analysis of vascular and scaffold morphology |
18 months |
| IVUS OCT subgroup: Incomplete apposition (baseline), persisting incomplete apposition, late incomplete apposition |
2 years (if analyzable) |
| Ischemia driven Non-Target Vessel Revascularization (ID non- TVR) |
30, 180 days and 1, 2, and 3 years |
| Lumen area |
post-procedure and at 2 years |
|
Target Sample Size
Modification(s)
|
Total Sample Size="1000"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
NIL at this time |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 2010. Recruitment in India has not yet begun. Recruitment of 1000 participants worldwide is expected. Approximately 105 patients overall will be enrolled in India, equating to approximately 15 patients at each site. |