Status:
COMPLETED
The Initial Double-Blind Drug-Eluting Stent vs Bare-Metal Stent Study.
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary lesions as c...
Detailed Description
This is a multicenter (19 sites), prospective, randomized study. This study has a 2 arm design assessing the safety and effectiveness of the sirolimus coated BxTM VELOCITY stent to the bare metal BxTM...
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 of 18mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
- Target lesion is \>= 2.5 and \<= 3.5mm in diameter (visual estimate);
- Target lesion is located in a native coronary artery which can be covered by one stent (single lesion);
- Target lesion stenosis is \>50% and \<100% (TIMI I) (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 \>=50% stenosis;
- Have an ostial target lesion;
- Angiographic evidence of thrombus within target lesion;
- Calcified lesions which cannot be successfully predilated;
- Ejection fraction \<=30%;
- Totally occluded vessel (TIMI 0 level);
- Target lesion involves bifurcation including a side branch \>=2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require side branch stenting which is likely to occur if side branch is diseased and intended to be stented;
- Planned Direct Stenting.
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00233805
Start Date
August 1 2000
End Date
December 1 2007
Last Update
August 6 2008
Active Locations (1)
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1
Dr Marie-Claude Morice
Massy, France, F- 91300