Status:
COMPLETED
The BRIDGE Registry: Safety and Efficacy Registry of Bx Cypher Stent
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to establish the safety and efficacy of the treatment with Cypher DES in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in l...
Detailed Description
This is a prospective, multicenter, comparative, non randomised, open registry of 1000 patients who will be followed up to 12 months at 100 sites in France. Patients will be screened according to nor...
Eligibility Criteria
Inclusion
- NIDDM treated with oral antidiabetics for at least 3 months, or IDDM treated for at least 3 months with documented HbA1C;
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
- Target lesion stenosis is \>50% (visual estimate);
- Target vessel diameter, between 2.5 and 3.0 mm
- Target lesion length minimum 15 mm and maximum 30mm
Exclusion
- CK and CK-MB enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment;
- Has unstable angina classified as Braunwald III B and A or C I-II-III, or is having a peri-infarction;
- Unprotected left main coronary disease with \>=50% stenosis;
- Significant (\>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure;
- Have an ostial target lesion;
- Documented left ventricular ejection fraction \<=30%;
- In-Stent restenosis;
- Chronic total occlusion.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
639 Patients enrolled
Trial Details
Trial ID
NCT00232804
Start Date
June 1 2002
End Date
February 1 2004
Last Update
October 10 2007
Active Locations (1)
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1
Université de Lille, Hôpital cardiologique
Lille, France, 59037