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| Sponsored by: |
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 |
| MedlinePlus related topics: | Coronary Artery Disease |
| ChemIDplus related topics: | Everolimus |
| 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.1 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.2,3 Despite established guidelines that recommend 6-12 months dual antiplatelet therapy, patients with DES implants frequently stop taking their medication early. Consequently, XIENCE™ 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™ EECSS, which is expected to represent the range of clinical use during commercialization.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Vivian Mao | 408-845-1489 | vivian.mao@av.abbott.com |
| India | |||||
| Max Devki Devi Heart & Vascular Institute | Recruiting | ||||
| New Delhi, India, 110017 | |||||
| Contact: Ashok Seth | |||||
| Contact: , MD | |||||
| Principal Investigator: Ashok Seth, MD | |||||
| Apollo Hospital | Recruiting | ||||
| Hyderabaad, India, 500033 | |||||
| Contact: P C Rath, MD | |||||
| Principal Investigator: P C Rath, MD | |||||
| Deenanath Mangeshkar Hospital & Research Center | Not yet recruiting | ||||
| Pune, India, 411004. | |||||
| Contact: Sheerish Sathe, MD | |||||
| Principal Investigator: Sheerish Sathe, MD | |||||
| Poona Hospital And Research Centre | Not yet recruiting | ||||
| Pune, India, 411030 | |||||
| Contact: J Hiremath, MD | |||||
| Principal Investigator: J S Hiremath, MD | |||||
| G.B.Pant Hospital | Not yet recruiting | ||||
| New Delhi, India, 110 070 | |||||
| Contact: Vijay Trehan, MD | |||||
| Principal Investigator: Vijay Trehan, MD | |||||
| Fortis Hospital | Recruiting | ||||
| New Delhi, India, 110 070 | |||||
| Contact: U Kaul, MD | |||||
| Principal Investigator: U Kaul, MD | |||||
| Escorts Heart Institute & Research Centre | Recruiting | ||||
| New Delhi, India, 110 070 | |||||
| Contact: U Kaul, MD | |||||
| Principal Investigator: U Kaul, MD | |||||
| Escorts Heart & Superspeciality Institute Ltd. | Not yet recruiting | ||||
| Amritsar,, India | |||||
| Contact: A Chopra, MD | |||||
| Principal Investigator: A Chopra, MD | |||||
| Holy Family Hospital | Recruiting | ||||
| Mumbai, India, 400050 | |||||
| Contact: Brian Pinto, MD | |||||
| Principal Investigator: Brian Pinto, MD | |||||
| Lisie Heart Institute,Lisie Hosp. | Recruiting | ||||
| Cochin, India | |||||
| Contact: Rony Mathew, D | |||||
| Principal Investigator: Rony Mathew, MD | |||||
| Madras Medical Mission | Recruiting | ||||
| Chennai, India, 600 037 | |||||
| Contact: Ajit Mullasari, MD | |||||
| Principal Investigator: Ajit Mullasari, MD | |||||
| Wockhardt Hospital and Heart Institute. | Not yet recruiting | ||||
| Bangalore, India, 560052 | |||||
| Contact: Ranganath Nayak, MD | |||||
| Principal Investigator: Ranganath Nayak, MD | |||||
| SAL Hospital And Medical Institute | Recruiting | ||||
| Ahmedabad, India, 380054 | |||||
| Contact: Tejas M Patel, MD | |||||
| Principal Investigator: Tejas M Patel, MD | |||||
| India, Gujarat | |||||
| Krishna Heart Institute, | Recruiting | ||||
| Ahemdabad, Gujarat, India, 380 006 | |||||
| Contact: Tejas M. Patel, MD | |||||
| Principal Investigator: Tejas M Patel | |||||
| India, Punjab | |||||
| Dayanand Medical College & Hospital | Not yet recruiting | ||||
| Ludhiana, Punjab, India, 141001 | |||||
| Contact: Wander, MD | |||||
| Principal Investigator: Wander, MD | |||||
| India, Tamilnadu | |||||
| Christian Medical Center (CMC) | Not yet recruiting | ||||
| Vellore, Tamilnadu, India, 632004 | |||||
| Contact: Sunil T Chandy, MD | |||||
| Principal Investigator: Sunil T Chandy, MD | |||||
| Abbott Vascular |
| 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 |
| First Received: | February 28, 2008 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00631228 |
| Health Authority: | India: Central Drugs Standard Control Organization |
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