Coronary Artery Disease
Conditions
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.
Interventions
drug-eluting stent
DEVICEuncoated Bx Velocity stent
bare-metal stent
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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; 2. 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; 3. Target vessel diameter at the lesion site is \>=2.50mm and \<=3.0mm in diameter (visual estimate); 4. Target lesion is \>=15mm and \<=32mm in length (visual estimate); 5. Target lesion stenosis is \>50% and \<100% (visual estimate);
Exclusion criteria
1. 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; 2. Has unstable angina classified as Braunwald III B or C and A I-II-III, or is having a peri infarction; 3. Unprotected left main coronary disease with \>=50% stenosis; 4. Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff; 5. Have an ostial target lesion; 6. Angiographic evidence of thrombus within target lesion; 7. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated; 8. Documented left ventricular ejection fraction \<=25%;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-stent minimum lumen diameter (MLD). | 8 months. |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
| In-lesion MLD. | 8 months. |
| Device success (final residual diameter stenosis of < 50%). | any time post-procedure. |
| Target vessel revascularization. | 9 months. |
| Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. | 9 months. |
| Target lesion revascularization. | 9 months. |
Countries
Germany
Outcome results
None listed