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| Sponsor: | Abbott Vascular |
|---|---|
| Information provided by: | Abbott Vascular |
| ClinicalTrials.gov Identifier: | NCT00631228 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Disease Coronary Artery Disease Coronary Restenosis |
Device: XIENCE V® Everolimus Eluting Coronary Stent |
Phase IV |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | XIENCE V® Everolimus Eluting Coronary Stent System India Post-Marketing Registry |
| Estimated Enrollment: | 1000 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
The group will be monitored to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
|
Device: XIENCE V® Everolimus Eluting Coronary Stent
Drug eluting stent implantation stent in the treatment of coronary artery disease
|
Long term surveillance studies using a drug eluting stent (DES) may help elucidate mechanisms responsible for death, myocardial infarction, and late stent thrombosis risks not observed during controlled pre-market trials. This study will evaluate XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) performance in the "real world" when used by a broad group of physicians at a variety of health care facilities. Consequently, this protocol will include all consecutively enrolled patients in India who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.
Adjunctive anti-platelet therapy is a critical factor in optimizing long term DES safety. Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE V® EECSS India Post-marketing Registry (XIENCE V® India) follow-up will document patient adherence and persistence with adjunctive antiplatelet drug therapy at several time points throughout the study.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The group will be all consecutively enrolled patients in India treated by a broad group of physicians at a variety of health care facilities, who consent to participate and receive the XIENCE V® EECSS, which is expected to represent the range of clinical use during commercialization.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| India | |
| Max Devki Devi Heart & Vascular Institute | |
| New Delhi, India, 110017 | |
| Apollo Hospital | |
| Hyderabaad, India, 500033 | |
| Poona Hospital And Research Centre | |
| Pune, India, 411030 | |
| Escorts Heart & Superspeciality Institute Ltd. | |
| Amritsar, India | |
| Lisie Heart Institute,Lisie Hosp. | |
| Cochin, India | |
| Escorts Heart Institute & Research Centre | |
| New Delhi, India, 110 070 | |
| Holy Family Hospital | |
| Mumbai, India, 400050 | |
| Fortis Hospital | |
| New Delhi, India, 110 070 | |
| Madras Medical Mission | |
| Chennai, India, 600 037 | |
| SAL Hospital And Medical Institute | |
| Ahmedabad, India, 380054 | |
| Heart & General Hospital | |
| Jaipur, India | |
| Jehangir Hospital | |
| Pune, India, 411001 | |
| India, Andhra Pradesh | |
| CARE Hospital | |
| Hyderabaad, Andhra Pradesh, India, 500034 | |
| India, Gujarat | |
| Krishna Heart Institute, | |
| Ahemdabad, Gujarat, India, 380 006 | |
| India, Punjab | |
| Dayanand Medical College & Hospital | |
| Ludhiana, Punjab, India, 141001 | |
| India, Tamilnadu | |
| Christian Medical Center (CMC) | |
| Vellore, Tamilnadu, India, 632004 | |
| Principal Investigator: | Ashok Seth, MD | Max Devki Devi Heart & Vascular Institute |
| Principal Investigator: | Tejas Patel, MD | Krishna Heart Institute |
More Information
| Responsible Party: | Abbott Vascular ( Vivian Mao ) |
| Study ID Numbers: | 07-378 |
| Study First Received: | February 28, 2008 |
| Last Updated: | June 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00631228 History of Changes |
| Health Authority: | India: Central Drugs Standard Control Organization |
|
drug eluting stents stents Angioplasty coronary artery disease total coronary occlusion |
coronary artery restenosis stent thrombosis vascular disease myocardial ischemia coronary artery stenosis |
|
Arterial Occlusive Diseases Everolimus Heart Diseases Immunologic Factors Myocardial Ischemia Physiological Effects of Drugs Vascular Diseases Arteriosclerosis |
Coronary Restenosis Coronary Stenosis Immunosuppressive Agents Pharmacologic Actions Coronary Disease Cardiovascular Diseases Coronary Artery Disease |