The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.
- Conditions
- Coronary Artery Disease
- Interventions
- Device: sirolimus-coated Bx Velocity stentDevice: uncoated Bx Velocity stent
- Registration Number
- NCT00235144
- Lead Sponsor
- Cordis Corporation
- Brief Summary
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.
- Detailed Description
This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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;
- Treatment of a single de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with multiple lesions can be included only if the other lesions do not require treatment;
- Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visual estimate);
- Target lesion is >=15mm and <=32mm in length (visual estimate);
- Target lesion stenosis is >50% and <100% (visual estimate);
- 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 and A I-II-III, or is having a peri infarction;
- Unprotected left main coronary disease with >=50% stenosis;
- Significant (>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
- Have an ostial target lesion;
- Angiographic evidence of thrombus within target lesion;
- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
- Documented left ventricular ejection fraction <=25%;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 sirolimus-coated Bx Velocity stent drug-eluting stent 2 uncoated Bx Velocity stent bare-metal stent
- Primary Outcome Measures
Name Time Method In-stent minimum lumen diameter (MLD). 8 months.
- Secondary Outcome Measures
Name Time Method In-lesion MLD. 8 months. Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR. 1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure. Angiographic binary restenosis (>=50% diameter stenosis). 8 months. Target lesion revascularization. 9 months. Target vessel revascularization. 9 months. Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. 9 months. Device success (final residual diameter stenosis of < 50%). any time post-procedure.
Trial Locations
- Locations (2)
Med. Klinik und Poliklinik
🇩🇪Münster, Germany
Herzkatheterlabor und Praxisklinik
🇩🇪Hamburg, Germany