Coronary Artery Disease
Conditions
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.
Interventions
drug-eluting stent
bare metal stent
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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);
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| angiographic in-segment late loss | 8 months post-procedure |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| late loss | 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. |
| procedure success | 8 months post-procedure |
Countries
Germany
Outcome results
None listed