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Sponsored by: |
Cordis Corporation |
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Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00234455 |
The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease |
Device: drug eluting-stent Device: drug-eluting stent |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Evaluation of the Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With Bifurcation Lesions. |
Enrollment: | 86 |
Study Start Date: | June 2001 |
Study Completion Date: | April 2007 |
Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group)
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Device: drug eluting-stent
PCI
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2
stents in both the main and side branches (stent/stent group)
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Device: drug-eluting stent
PCI
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This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll - Medical Affairs Director ) |
Study ID Numbers: | EC01-02 |
Study First Received: | October 5, 2005 |
Last Updated: | April 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00234455 |
Health Authority: | Italy: 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 |