The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions. (DOMINO)
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-III) OR patients with documented silent ischemia; Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion; Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate); Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent; Target lesion stenosis is > 50% and < 100% (visual estimate). Exclusion Criteria: A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; Unprotected left main coronary disease with more than 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; Calcified lesions which cannot be successfully predilated; Ejection fraction less than 30%; Totally occluded vessel (TIMI 0 level); Direct Stenting;
Sites / Locations
- Cardiothoracic Center Liverpool
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
1
2
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
CYPHER™ Sirolimus-eluting Coronary Stent