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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Cypher Sirolimus-Eluting Stent
Taxus Paclitaxel-Eluting Stent
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Institut Hospitalier Jacques Cartier

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 4, 2005
Last Updated
April 25, 2007
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00235092
Brief Title
The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
Official Title
A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1335 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cypher Sirolimus-Eluting Stent
Intervention Type
Device
Intervention Name(s)
Taxus Paclitaxel-Eluting Stent
Primary Outcome Measure Information:
Title
The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Claude Morice, MD
Organizational Affiliation
Institut Hospitalier Jacques Cartier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16493102
Citation
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.
Results Reference
result

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

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