Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Phase 3
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: 4.0 CYPHER Sirolimus-Eluting Coronary Stent
- Registration Number
- NCT00232752
- Lead Sponsor
- Cordis Corporation
- Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 4.0 CYPHER Sirolimus-Eluting Coronary Stent -
- Primary Outcome Measures
Name Time Method The primary endpoint is in-lesion late loss at 6 months post-procedure by QCA. 6 months post-procedure
- Secondary Outcome Measures
Name Time Method Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-proced 30 days and 6, 9, and 12 months, and 2, 3, 4 and 5 years post-procedure Angiographic in-stent and in-lesion binary restenosis (³50% diameter stenosis) 6 months post-procedure by QCA. 6 months post-procedure In-stent and in-lesion minimum lesion diameter (MLD) at 6 months post-procedure. 6 months post-procedure Target lesion revascularization (TLR) at 6 and 9 months post-procedure. 6 and 9 months post-procedure Target vessel revascularization (TVR) at 6 and 9 months post-procedure. 6 and 9 months post-procedure Target vessel failure (TVF) at 6 and 9 months post-procedure. 6 and 9 months post-procedure Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of approximately 50 patients at selected centers. post-procedure and six months in a subset of approximately 50 patients Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. End of study Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. End of Study Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay. during the hospital stay
Trial Locations
- Locations (1)
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States