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| Name | Class |
|---|---|
| Cordis Medizinische Apparate GmbH | OTHER |
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The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).
This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers).
A total of 110 patients with at least two de novo native coronary artery lesions (lesion A, lesion B) ≤ 30 mm in length and ≥ 2.25 mm to < 3.0 mm in diameter by visual estimate will be enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A and B.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Cypher Stent |
|
| 2 | Active Comparator | Taxus Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-eluting TAXUS(TM) | Device | TAXUS(TM) Paclitaxel-eluting stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is angiographic in-stent late loss at 8-months follow-up as determined by quantitative coronary angiography | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion and vessel revascularization (TLR, TVR) | 12 months | |
| Major adverse cardiac events (MACE) at 30 days, 8 and 12 months | 30 days, 8 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manfred Zehender, MD PhD | University Clinic Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert-Ludwig University Clinic | Freiburg im Breisgau | Baden-Wurttemberg | 79116 | Germany |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Sirolimus eluting Cypher Select(TM) |
| Device |
Sirolimus eluting Cypher Select(TM) stent |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |