Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)

Last updated: September 15, 2009
Sponsor: Cordis Corporation
Overall Status: Completed

Phase

3

Condition

Coronary Artery Disease

Chest Pain

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT00232765
P00-6302
  • Ages > 18
  • All Genders

Study Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or non-pregnant female patients minimum 18 years of age

  2. 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;

  3. Target lesion is 2.50mm and 3.5mm in diameter (visual estimate);

  4. Target lesion is 15mm and 30mm in length (visual estimate);

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

Exclusion

Exclusion Criteria:

  1. 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;

  2. Has unstable angina classified as Braunwald III B or C, or is having a periinfarction;

  3. Documented Left ventricular ejection fraction 25%;

  4. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;

  5. Target lesion involves bifurcation including a diseased side branch 2.5mm in diameter (either stenosis of both main vessel and major branch or stenosis of just majorbranch) that would require treatment;

Study Design

Total Participants: 1058
Study Start date:
February 01, 2001
Estimated Completion Date:
November 30, 2008

Study Description

This is a multicenter (55 sites), prospective, 2-arm randomized, double-blind study designed to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent as compared to the uncoated Bx VELOCITYTM stent. A total of 1100 patients will be entered in the study and will be randomized on a 1:1 basis. Patients with de novo native coronary artery lesions >/=15mm and </=30mm in length and >/=2.50mm to </=3.5mm in diameter by visual estimate who meet all eligibility criteria will be either randomized to the sirolimus-coated Bx VELOCITYTM stent or the uncoated Bx VELOCITYTM stent. Patients will be followed at 30 days, 3, 6, 9 and 12 months, and 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with approximately 850 patients having repeat angiography at 8 months. A subset of approximately 17 centers will participate in an intravascular ultrasound (IVUS) sub study, in which all patients at these centers will be enrolled in the sub study. Additionally, data will be collected for a medical economic analysis. These data will include costs associated with the index hospitalization and length of stay, and rehospitalizations during the 12-month follow-up period. This is a single lesion treatment study. Patients who have had interventions of other lesions within 30 days of the study procedure or have interventions planned after the index procedure are excluded. It is anticipated that the total length of the study will be 101 months: 5 months to complete patient enrollment and 8 years for follow-up.

Connect with a study center

  • New York Presbyterian Hospital/Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

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