The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

Last updated: August 5, 2008
Sponsor: Cordis Corporation
Overall Status: Completed

Phase

2/3

Condition

Thrombosis

Myocardial Ischemia

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT00232791
EC03-04
  • Ages 18-85
  • All Genders

Study Summary

The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Single treatment of de novo lesion in a coronary artery which can be appropriatelycovered by a study stent up to 23mm in length in patients with single or multivesseldisease; patients with multiple lesions can be included only if the other lesions aresuccessfully treated before the target lesion;

  3. Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);

  4. Target lesion is located in a native coronary artery with a maximum lesion length thatcan be adequately covered by a single 23 mm stent;

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

Exclusion

Exclusion Criteria:

  1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless theCK and CK-MB enzymes are back to normal;

  2. Unprotected left main coronary disease with more than 50% stenosis;

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

  4. Have an ostial target lesion;

  5. Angiographic evidence of thrombus within target lesion;

  6. Calcified lesions which cannot be successfully predilated;

  7. Ejection fraction less than 30%;

  8. Totally occluded vessel (TIMI 0 level);

  9. Direct Stenting;

Study Design

Total Participants: 102
Study Start date:
January 01, 2004
Estimated Completion Date:
March 31, 2005

Study Description

This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions <23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Connect with a study center

  • Cardiothoracic Center Liverpool

    Liverpool, L14 3PE
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.