Study of the 4.0mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions

Last updated: December 1, 2009
Sponsor: Cordis Corporation
Overall Status: Completed

Phase

3

Condition

Thrombosis

Hypercholesterolemia

Heart Disease

Treatment

N/A

Clinical Study ID

NCT00232752
P03-6319
  • Ages > 18
  • All Genders

Study Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion late loss in patients with de novo native coronary artery lesions.

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 lesions treatable with 4mm stent (visual estimate);

  4. Target lesion is 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;

Study Design

Total Participants: 100
Study Start date:
September 01, 2003
Estimated Completion Date:
November 30, 2009

Connect with a study center

  • Brigham & Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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