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Sponsored by: |
Abbott Vascular |
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Information provided by: | Abbott Vascular |
ClinicalTrials.gov Identifier: | NCT00676520 |
This prospective, open-label, multi-center, observational, single-arm registry is designed to evaluate XIENCE V EECSS continued safety and efficacy during commercial use in real world settings.
Condition | Intervention | Phase |
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Coronary Artery Disease |
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 (EECSS) USA Post-Approval Study |
Estimated Enrollment: | 5000 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Single arm registry
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Device: XIENCE™ V Everolimus Eluting Coronary Stent
Single-arm registry designed to evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings.
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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 the United States of America (USA) 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 V EECSS USA Post-Approval Study (XIENCE V USA) 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 |
Patients who agree to participate and who recieve a XIENCE V EECSS to evaluate continued safety and effectiveness during commercial use in real world settings from a wide variety of physician practices.
Inclusion Criteria:
Exclusion Criteria:
Age limit to be determined by physicians.
Contact: Vivian Mao | 408-845-1489 | vivian.mao@av.abbott.com |
Principal Investigator: | James Hermiller, MD | Heart Center of Indianapolis |
Principal Investigator: | Mitch Krucoff, MD | Duke University |
Responsible Party: | Abbott Cardiovascular Systems, Inc., A Subsidiary of Abbott Vascular, Inc. ( Vivian Mao ) |
Study ID Numbers: | 06-374 |
Study First Received: | October 16, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00676520 |
Health Authority: | United States: Food and Drug Administration |
Angioplasty Coronary Restenosis Coronary Artery Disease Coronary Artery Restenosis Coronary Artery Stenosis Total Artery Occlusion |
Stents Stent Thrombosis Total Coronary Occlusion Vascular Disease Myocardial Ischemia |
Everolimus Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Vascular Diseases Constriction, Pathologic Ischemia |
Arteriosclerosis Coronary Restenosis Coronary Stenosis Thrombosis Coronary Disease Coronary Occlusion Coronary Artery Disease |
Immunologic Factors Physiological Effects of Drugs Cardiovascular Diseases Immunosuppressive Agents Pharmacologic Actions |