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The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions. (E-SIRIUS)

C

Cordis

Status and phase

Completed
Phase 3

Conditions

Coronary Artery Disease

Treatments

Device: sirolimus-coated Bx Velocity stent
Device: uncoated Bx Velocity stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00235144
EC00-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

353 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

353 participants in 2 patient groups

1
Experimental group
Description:
drug-eluting stent
Treatment:
Device: sirolimus-coated Bx Velocity stent
2
Active Comparator group
Description:
bare-metal stent
Treatment:
Device: uncoated Bx Velocity stent

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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