A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT00495898
- Lead Sponsor
- Cordis Corporation
- Brief Summary
The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.
- Detailed Description
This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions \<= 42 mm in length and \>=2.5mm and \<=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month).
It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
- Manifest diabetes mellitus, proven by fasting glucose (12 h) > 127 mg/dl or oral glucose challenge: >= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin;
- Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended;
- Target vessel diameter at the lesion site is >= 2.5mm and <= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width);
- Target lesion is <= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length);
- Target lesion diameter stenosis is > 50% and <100% (visual estimate);
None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method angiographic in-segment late loss 8 months post-procedure
- Secondary Outcome Measures
Name Time Method late loss 8 months post-procedure angiographic binary restenosis 8 months post-procedure target lesion revascularization (TLR) 8 months post-procedure target vessel revascularization (TVR) 8 months post-procedure target vessel failure (TVF) 8 months post-procedure procedure success 8 months post-procedure lesion success rate 0 resource use 1 year post-procedure productivity loss 1 year post-procedure Major Adverse Cardiac Events (MACE) 30 days, and 8 and 12 months.
Trial Locations
- Locations (1)
University of Essen
🇩🇪Essen, Germany
University of Essen🇩🇪Essen, Germany