The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus

Phase 4

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00235092
• Lead Sponsor: Cordis Corporation

Brief Summary

The main objective of this study is to compare the performance of the Cypher sirolimus-eluting and the Taxus paclitaxel-eluting stent systems in a prospective, multi-center, randomized clinical study.

Detailed Description

This is a prospective, randomized study conducted at 90 centers in Europe, Latin-America and Asia. A total of 1335 patients will be entered into the study and will be randomized on a 1:1 basis to either the sirolimus-eluting or the paclitaxel-eluting stent system. All patients will have repeat angiography at eight months and will be followed for 24 months post-procedure.

Study Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Study Completion: 2006-03
• Status Verified: 2007-04
• Last Update Submitted: 2007-04-25
• Last Update Posted: 2007-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1335

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-III) OR patients with documented silent ischemia;
2. Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
3. Ostial lesions;
4. Bifurcations;
5. Target vessel diameter of both lesions must be >=2.25mm and <=3.0mm in diameter (visual estimate);
6. One target lesion must be at least 15 mm in length and the second lesion has to be at least 10 mm in length with no upper limit on either;
7. Target lesion stenosis for both lesions 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 72 hours and the CK and CK-MB enzymes remain above normal at the time of treatment;

2. Has unstable angina classified as Braunwald A I-II-III;

3. Any of the lesions is an unprotected left main coronary disease with >=50% stenosis;

4. Angiographic evidence of thrombus within target lesion;

5. Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);

6. Documented left ventricular ejection fraction <=25%;

7. Totally occluded vessel (TIMI 0 level) (applies to both lesions);

8. Prior stent within 10mm of target lesion (applies to both lesions).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.

Trial Locations

Locations (1)

Institut Hospitalier Jacques Cartier; 🇫🇷 Massy, France