The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.

Last updated: October 30, 2008
Sponsor: Cordis Corporation
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Thrombosis

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00381420
P01-6307
  • Ages > 18
  • All Genders

Study 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® Stent Delivery Systems.

The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year, 3 and 5 years).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of angina pectoris as defined by Canadian Cardiovascular SocietyClassification (CCS I, II, III, IV) OR unstable angina pectoris (BraunwaldClassification B&C, I-II) OR patients with documented silent ischemia;

  • Single treatment of de novo lesion in a major coronary artery in patients with singleor multi-vessel disease; patients with multiple lesions can be included only if theother lesions do not require treatment;

  • Target vessel diameter at the lesion site is >=2.50mm and <=3.0mm in diameter (visualestimate);

  • Target lesion is >=15mm and <=32mm in length (visual estimate);

  • Target lesion stenosis is >50% and <100% (visual estimate);

Exclusion

Exclusion Criteria:

  • Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documentedtotal CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymesremains 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 aperi infarction;

  • Unprotected left main coronary disease with >=50% stenosis;

  • Significant (>50%) stenoses proximal or distal to the target lesion that might requirerevascularization or impede runoff;

  • Have an ostial target lesion;

  • Angiographic evidence of thrombus within target lesion;

  • Heavily calcified lesion which cannot be successfully predilated;

  • Documented left ventricular ejection fraction <=25%.

Study Design

Total Participants: 100
Study Start date:
March 01, 2001
Estimated Completion Date:
June 30, 2008

Study Description

This is a multicenter ,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 Raptor® Stent Delivery Systems. A total of 100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients who meet the eligibility criteria will be either randomized to Treatment A or Treatment B. Neither the investigator nor the patient will know which stent will be implanted. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4 and 5 years post-procedure, with all patients undergoing repeat angiography at 8 months. Additionally, medical costs associated with the index hospitalization and length of stay, and repeat hospitalizations and costs associated with other relevant medical resource use during the 5 years follow-up period will be collected and analyzed.