Status:
COMPLETED
The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as...
Detailed Description
This is a multicenter ,prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent to the uncoated Bx VE...
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) OR patients with documented silent ischemia;
- Single treatment of de novo lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
- Target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate);
- Target lesion is \>=15mm and \<=32mm in length (visual estimate);
- Target lesion stenosis is \>50% and \<100% (visual estimate);
Exclusion
- Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
- Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction;
- Unprotected left main coronary disease with \>=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;
- Heavily calcified lesion which cannot be successfully predilated;
- Documented left ventricular ejection fraction \<=25%.
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00381420
Start Date
March 1 2001
End Date
June 1 2008
Last Update
October 31 2008
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