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

NCT00235092 | Completed Phase 4 DMC

• 1 other identifier: EC03-02
• Study Type: interventional
• Target: 1,335
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

Interventions

Cypher Sirolimus-Eluting Stent DEVICE

Taxus Paclitaxel-Eluting Stent DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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%;
• \. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
• \. Prior stent within 10mm of target lesion (applies to both lesions).

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Institut Hospitalier Jacques Cartier

Massy, France

Location

Related Publications (1)

• 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.

  PMID: 16493102 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Marie-Claude Morice, MD

  Institut Hospitalier Jacques Cartier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 10, 2005
• Study Start: August 1, 2003
• Study Completion: March 1, 2006
• Last Updated: April 27, 2007

Record last verified: 2007-04

Locations

FR (1)