Status:
COMPLETED
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary 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-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de novo native coronary artery...
Detailed Description
This is a multicenter (approximately 10 - 14 sites), prospective, non-randomized study. The study is designed to evaluate the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in p...
Eligibility Criteria
Inclusion
- Male or non-pregnant female patients minimum 18 years of age
- 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;
- Target lesion is 20mm 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, or is having a peri infarction;
- Documented Left ventricular ejection fraction 25%;
- Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00232739
Start Date
September 1 2003
End Date
August 1 2009
Last Update
March 16 2010
Active Locations (1)
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1
Lenox Hill Hospital
New York, New York, United States, 10021