| CTRI Number |
CTRI/2008/091/000213 [Registered on: 02/07/2009] |
| Last Modified On: |
16/12/2011 |
| Post Graduate Thesis |
|
| Type of Trial |
|
|
Type of Study
|
|
| Study Design |
Other |
Public Title of Study
Modification(s)
|
XIENCE V India: XIENCE V Everolimus Eluting Coronary Stent System (EECSS) India Post-Marketing Registry |
Scientific Title of Study
Modification(s)
|
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) India Post-Marketing Registry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 7-378 v. 3.2 7.2.08 |
Protocol Number |
| NCT00631228 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashok Seth, MD |
| Designation |
|
| Affiliation |
|
| Address |
Escorts Heart Institute & Research Centre
Okhla Road
New Delhi
DELHI
110025
India |
| Phone |
+91-11-26825000 / 01 ? Extn: 4289 |
| Fax |
+91-11-26825058 |
| Email |
ashok.seth@ehirc.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumati Randeo |
| Designation |
|
| Affiliation |
Abbott Vascular |
| Address |
Office Floor, Crowne Plaza Surya
New Delhi
DELHI
110025
India |
| Phone |
+91-11-40530121 |
| Fax |
+91-11- 40530199 |
| Email |
sumati.randeo@av.abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumati Randeo |
| Designation |
|
| Affiliation |
|
| Address |
Office Floor, Crowne Plaza Surya
New Delhi
DELHI
110025
India |
| Phone |
+91-11-40530121 |
| Fax |
+91-11- 40530199 |
| Email |
sumati.randeo@av.abbott.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abbott Vascular |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 18 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| P.C. Rath |
Apollo Hospital |
Jubilee Hills,-500033
Hyderabad
ANDHRA PRADESH |
|
| A. Sreenivas Kumar , MD |
CARE Hospital |
,-500034
Hyderabad
ANDHRA PRADESH |
|
| Sunil Thomas Chandy |
Christian Medical College |
Ida Scudder Road,Vellore-632004
|
|
| G.S. Wander |
Dayanand Medical College & Hospital |
Tagore Nagar Civil Lines,Ludhiana-141001
|
|
| U.kaul |
Escorts Heart Institute & Research Centre |
Okhla Road,-
New Delhi
DELHI |
|
| A.Chopra |
Escorts Heart & Superspeciality Institute Ltd. |
Majitha Verka Bypass Road,-
Amritsar
PUNJAB |
|
| Ashok Seth |
Escorts Heart Institute & Research Centre |
Okhla Road,-110025
New Delhi
DELHI |
+91-11-26825000
ashok.seth@ehirc.com |
| U.Kaul |
Fortis Hospital |
Sector B, Pocket 1, Aruna Asaf Ali Marg,Vasant Kunj-110 070
New Delhi
DELHI |
|
| Prakash Chandwani |
Heart & General Hospital |
,-
Jaipur
RAJASTHAN |
|
| Brian Pinto |
Holy Family Hospital |
Hill Road, Bandra (West) ,-400050
Mumbai
MAHARASHTRA |
|
| J. S. Dugal |
Jehangir Hospital |
,-411001
Pune
MAHARASHTRA |
+91-20-26050550
|
| Tejas. M.Patel |
Krishna Heart Institute |
1st Floor, Parimal Cross Roads,Ahmedabad -380 006
|
|
| Rajendra Kumar Premchand |
Krishna Institute of Medical Sciences |
1-8-31/1, Minister Road,-
|
+91-40-27814910-19
kumarpre@hotmail.com |
| Rony Mathew |
Lissie Hospital |
Lisie Junction,Cochin-682 018
|
|
| Ajit Mullasari |
Madras Medical Mission |
Institute of Cardiovascular Diseases, Madras Medical Mission,Mogappair-600 037
Chennai
TAMIL NADU |
|
| Ashok Seth |
Max Devki Devi Heart & Vascular Institute |
2,Press Enclave Road,Saket,-110017
New Delhi
DELHI |
|
| J.S.Hiremath |
Poona Hospital And Research Centre |
27, Sadashiv Peth ,-411030
Pune
MAHARASHTRA |
|
| Tejas. M.Patel |
SAL Hospital And Medical Institute |
Opposite Doordarshan Drive-in Road ,-380054
Ahmadabad
GUJARAT |
|
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 18 |
| Name of Committee |
Approval Status |
| Apollo Hospitals Educational & Research Foundation |
Approved |
| CMC, Vellore Institutional Review Board |
Approved |
| Devki Devi Foundation |
Approved |
| Drug Trial Ethics Committee, Dayanand Medical College and Hospital |
Approved |
| Drug Trial Ethics Committee, Dayanand Medical College and Hospital. |
Approved |
| Escorts Heart Institute & Research Centre Independent Ethics Committee |
Approved |
| Ethics Committee For Research |
Approved |
| Ethics Committee, Poona Hospital & Research Centre. |
Approved |
| Ethics Committee,Escorts Heart & Superspeciality Institute |
Approved |
| Fortis Hosptial Ethis committee for research |
Approved |
| Heart and General Hospital Ethics Commiittee |
Approved |
| Institutional Ethical Committee Care Hospital |
Approved |
| JCDC Ethics Committee |
Approved |
| Krishna Institute of Medical Sciences Ethics Committee |
Approved |
| Lissie Hospital Ethics Committee |
Approved |
| Madras Medical Mission Institutional Ethics Committee |
Approved |
| Sujlam Independent Ethics Committee |
Approved |
| The Bandra Holy family Medical Research society |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Drug eluting stents,
stents,
Angioplasty,
Coronary artery disease,
Total coronary occlusion,
Coronary artery restenosis,
Stent thrombosis,
Vascular disease,
Myocardial ischemia,
Coronary artery stenosis,
Coronary Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
XIENCE V Everolimus Eluting Coronary Stent |
Stent |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
The patient agrees to participate in this study by signing the EC approved informed consent form. Alternatively, the patient's legally authorized representative agrees to the patient's participation in this study and signs the informed consent form |
|
| ExclusionCriteria |
| Details |
The inability to obtain an informed consent is an exclusion criterion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stent thrombosis rates as defined by Academic Research Consortium (ARC) |
Annually through to 5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Composite rate of cardiac death and any MI (Q-wave and non Q-wave) |
30, 180 days and at 2, 3, 4 and 5 years |
| Composite rate of all death and any MI (Q-wave and non Q-wave) |
30, 180 days and at 1, 2, 3, 4 and 5 years |
| Composite rate of cardiac death , any MI (Q-wave and non Q-wave) attributed to the target vessel, and target lesion revascularization (PCI and CABG) |
30, 180 days and at 1, 2, 3, 4 and 5 years |
| Death (cardiac death, vascular death, and non-cardiovascular death) |
30, 180 days and at 1, 2, 3, 4 and 5 years |
| Any MI (Q-wave and non Q-wave) |
30, 180 days and at 1, 2, 3, 4 and 5 years |
| Major bleeding complications |
14, 30, 180 days and at 1, 2, 3, 4 and 5 years |
| Compliance and therapy interruptions with prescribed adjunctive anti-platelet therapy |
14, 30, 180 days and at 1, 2, 3, 4 and 5 years |
| Revascularization (target lesion, target vessel [TVR], and non-target vessel) (PCI and CABG) |
30, 180 days and at 1, 2, 3, 4 and 5 years |
| Clinical device and procedural success |
Acute |
| Patient health status (symptoms, physical function, and quality of life) assessed by the Seattle Angina Questionnaire |
at baseline, 180 days, and 1 year. |
| Stent thrombosis |
24 hours (acute) and 30 days (sub-acute) |
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization (PCI and CABG) |
30, 180 days and 1, 2, 3, 4, and 5 years |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
03/06/2008 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
XIENCE V India is a prospective, open-label, multi-center, observational, single-arm registry to evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings.
|