Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECTâ„¢ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER â„¢ Sirolimus-eluting Coronary Stent.
This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECTâ„¢ Sirolimus-eluting Coronary Stent as compared to the CYPHERâ„¢ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECTâ„¢ stent or the CYPHERâ„¢ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CYPHER SELECTâ„¢ Sirolimus-eluting Coronary Stent |
|
| 2 | Active Comparator | CYPHERâ„¢ Sirolimus-eluting Coronary Stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cypher Select | Device | CYPHER SELECTâ„¢ Sirolimus-eluting Coronary Stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic in-stent late loss | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent mean percent diameter stenosis | anytime post-procedure | |
| In-target vessel segment MLD | 6 months | |
| In-stent MLD |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| R. H. Stables, MD | Cardiothoracic Centre Liverpool | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic Center Liverpool | Liverpool | L14 3PE | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cypher | Device | CYPHERâ„¢ Sirolimus-eluting Coronary Stent |
|
|
| 6 months |
| Target Lesion Revascularization (TLR) | 6 months |
| Target Vessel Revascularization (TVR) | 6 months |
| Major Adverse Cardiac Events (MACE) | 30 days, 6 and 12 months |
| In-stent volume of restenosis determined by IVUS | 6 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |