The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

Launched by CORDIS CORPORATION · Oct 4, 2005

Keywords

ClinConnect Summary

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 rand...

Gender

ALL

Eligibility criteria

• 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;