Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)
Completed · Phase 3
Conditions studied: Coronary Artery Disease
In brief
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.
Key facts
- Study ID
- NCT00232765
- Run by
- Cordis US Corp.
- People needed
- 1058
- Starts
- 2001-02-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2009-09-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 2.50mm and 3.5mm in diameter (visual estimate);
- Target lesion is 15mm and 30mm in length (visual estimate);
- Target lesion stenosis is >50% and <100% (visual estimate);
You may not qualify if…
- 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;
- Target lesion involves bifurcation including a diseased side branch 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just major branch) that would require treatment;
Where it is running
- New York Presbyterian Hospital/Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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