Status:
COMPLETED
The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
Lead Sponsor:
Cordis US Corp.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 eith...
Eligibility Criteria
Inclusion
- 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;
- Treatment of up to two de novo native coronary artery lesions in a maximum of two major coronary arteries;
- Ostial lesions;
- Bifurcations;
- Target vessel diameter of both lesions must be \>=2.25mm and \<=3.0mm in diameter (visual estimate);
- 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;
- Target lesion stenosis for both lesions is \>50% and \<100% (visual estimate).
Exclusion
- 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;
- Has unstable angina classified as Braunwald A I-II-III;
- Any of the lesions is an unprotected left main coronary disease with \>=50% stenosis;
- Angiographic evidence of thrombus within target lesion;
- Heavily calcified lesion and/or calcified lesion, which cannot be successfully predilated (applies to both lesions);
- Documented left ventricular ejection fraction \<=25%;
- 8\. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
- 9\. Prior stent within 10mm of target lesion (applies to both lesions).
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
1335 Patients enrolled
Trial Details
Trial ID
NCT00235092
Start Date
August 1 2003
End Date
March 1 2006
Last Update
April 27 2007
Active Locations (1)
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1
Institut Hospitalier Jacques Cartier
Massy, France