The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions. (E-SIRIUS)
Coronary Artery Disease

About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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; Treatment of a single de novo native coronary artery 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 Criteria: 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 and/or calcified lesion which cannot be successfully predilated; Documented left ventricular ejection fraction <=25%;
Sites / Locations
- Herzkatheterlabor und Praxisklinik
- Med. Klinik und Poliklinik
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
drug-eluting stent
bare-metal stent