Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 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 lesions treatable with 4mm stent (visual estimate); Target lesion is 30mm 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, 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;
Sites / Locations
- Brigham & Women's Hospital
Arms of the Study
Arm 1
Experimental
1