Coronary Artery Disease
Conditions
Brief summary
The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.
Detailed description
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 SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ 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 SELECT™ stent or the CYPHER™ 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.
Interventions
DEVICECypher Select
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
DEVICECypher
CYPHER™ Sirolimus-eluting Coronary Stent
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia; 2. Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion; 3. Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate); 4. Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent; 5. Target lesion stenosis is \> 50% and \< 100% (visual estimate).
Exclusion criteria
1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; 2. Unprotected left main coronary disease with more than 50% stenosis; 3. Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; 4. Have an ostial target lesion; 5. Angiographic evidence of thrombus within target lesion; 6. Calcified lesions which cannot be successfully predilated; 7. Ejection fraction less than 30%; 8. Totally occluded vessel (TIMI 0 level); 9. Direct Stenting;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Angiographic in-stent late loss | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| In-target vessel segment MLD | 6 months |
| In-stent MLD | 6 months |
| Target Lesion Revascularization (TLR) | 6 months |
| In-stent mean percent diameter stenosis | anytime post-procedure |
| Major Adverse Cardiac Events (MACE) | 30 days, 6 and 12 months |
| In-stent volume of restenosis determined by IVUS | 6 months |
| Target Vessel Revascularization (TVR) | 6 months |
Countries
United Kingdom
Outcome results
None listed