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

NCT ID: NCT00235092

Last Updated: 2007-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1335 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2006-03-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cypher Sirolimus-Eluting Stent

Intervention Type: DEVICE

Taxus Paclitaxel-Eluting Stent

Intervention Type: DEVICE

Eligibility Criteria

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%;

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Principal Investigators

Marie-Claude Morice, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Hospitalier Jacques Cartier

Locations

Institut Hospitalier Jacques Cartier

Massy, , France

Countries

France

References

Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.

Reference Type: RESULT

PMID: 16493102 (View on PubMed)

Other Identifiers

EC03-02

Identifier Type: -

Identifier Source: org_study_id