Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Abbott Vascular |
---|---|
Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00631228 |
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.
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:
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 |
Responsible Party: | Abbott Vascular ( Vivian Mao ) |
Study ID Numbers: | 07-378 |
Study First Received: | February 28, 2008 |
Last Updated: | April 29, 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 |
Everolimus Arterial Occlusive Diseases Heart Diseases Immunologic Factors Myocardial Ischemia Vascular Diseases Constriction, Pathologic Ischemia |
Arteriosclerosis Immunosuppressive Agents Coronary Restenosis Coronary Stenosis Thrombosis Coronary Disease Coronary Occlusion Coronary Artery Disease |
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 |