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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00235092
First received: October 4, 2005
Last updated: April 25, 2007
Last verified: April 2007
  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.

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

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.

Estimated Enrollment: 1335
Study Start Date: August 2003
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235092

Locations
France
Institut Hospitalier Jacques Cartier
Massy, France
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Marie-Claude Morice, MD Institut Hospitalier Jacques Cartier
  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 April 17, 2014