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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00233818 |
The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: Sirolimus-coated Bx VELOCITY Stent |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of Sirolimus-Coated Modified BX VELOCITY Balloon-Expandable Stents for the Treatment of Patients With de Novo Native Coronary Artery Lesions |
Enrollment: | 15 |
Study Start Date: | February 2000 |
Study Completion Date: | June 2005 |
Arms | Assigned Interventions |
---|---|
1 | Device: Sirolimus-coated Bx VELOCITY Stent |
This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 months, and 48 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Netherlands | |
Erasmus Centrum Thoraxcentrum | |
Rotterdam, Netherlands, NL- 3015 GD |
Principal Investigator: | Patrick W Serruys, MD | Erasmus Centrum Thoraxcentrum |
Study ID Numbers: | EC99-07 |
Study First Received: | October 4, 2005 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00233818 |
Health Authority: | Netherlands: Independent Ethics Committee |
Sirolimus Arterial Occlusive Diseases Coronary Disease Heart Diseases Clotrimazole Miconazole |
Myocardial Ischemia Tioconazole Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |