The CYPHER™ Stent Study in Patients With Small de Novo Coronary Artery Lesions. (SVELTE)
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 1, 2, 3, 4) OR unstable angina pectoris (Braunwald Classification B&C 1-2) OR patients with documented silent ischemia; Single treatment of de novo lesion in a small vessel (2.25 - 2.75 mm) in a major coronary artery in patients with single or multivessel disease. Patients with multiple lesions can be included if the other lesions are successfully treated prior to the treatment of the intended lesion in the small vessel. Target vessel diameter >=2.25 and <=2.75mm (by visual estimation); Target lesion length >=15 and <=30 mm. 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 or the CK and CK-MB remains above normal at the time of the treatment; Has unstable angina classified as Braunwald A (1, 2, 3) or B & C 3; Unprotected left main coronary disease with >=50% stenosis; Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede inflow or runoff; Have an ostial target lesion; Lesion < 2.25 or > 2.75 mm in diameter; Totally occluded vessel (TIMI 0 level); Documented left ventricular ejection fraction £30%; Intention to treat the target lesion by direct stenting procedure.
Sites / Locations
- University Hospital, Swiss Cardiovascular CenterBern
Arms of the Study
Arm 1
Experimental
1
Cypher Sirolimus-Eluting Stent