The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

353 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

drug-eluting stent

Group Type EXPERIMENTAL

sirolimus-coated Bx Velocity stent

Intervention Type DEVICE

drug-eluting stent

2

bare-metal stent

Group Type ACTIVE_COMPARATOR

uncoated Bx Velocity stent

Intervention Type DEVICE

bare-metal stent

Interventions

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sirolimus-coated Bx Velocity stent

drug-eluting stent

Intervention Type DEVICE

uncoated Bx Velocity stent

bare-metal stent

Intervention Type DEVICE

Eligibility Criteria

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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%;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No