The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Device: Cypher Sirolimus-Eluting Stent Device: Taxus Paclitaxel-Eluting Stent |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems. |
- The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.
| Estimated Enrollment: | 1335 |
| Study Start Date: | August 2003 |
| Estimated Study Completion Date: | March 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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).
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00235092 History of Changes |
| Other Study ID Numbers: | EC03-02 |
| Study First Received: | October 4, 2005 |
| Last Updated: | April 25, 2007 |
| Health Authority: | France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus Everolimus Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013