Status:
COMPLETED
The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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;
- 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;
- Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
- 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;
- Target lesion stenosis is \> 50% and \< 100% (visual estimate).
Exclusion
- 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;
- Unprotected left main coronary disease with more than 50% stenosis;
- Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- Have an ostial target lesion;
- Angiographic evidence of thrombus within target lesion;
- Calcified lesions which cannot be successfully predilated;
- Ejection fraction less than 30%;
- Totally occluded vessel (TIMI 0 level);
- Direct Stenting;
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00232791
Start Date
January 1 2004
End Date
March 1 2005
Last Update
August 6 2008
Active Locations (1)
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1
Cardiothoracic Center Liverpool
Liverpool, United Kingdom, L14 3PE