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


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June 8, 2015

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Coronary Artery Disease Eligibility BX VELOCITY Stent NCT00235144

Eligibility BX VELOCITY Stent Coronary Artery Disease NCT00235144

Inclusion Criteria
18 years and older
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%
Medical concepts