Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
This study has been completed.
Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00235092
  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 IV

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: Paclitaxel Sirolimus
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

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 of Results:
Study ID Numbers: EC03-02
Study First Received: October 4, 2005
Last Updated: April 25, 2007
ClinicalTrials.gov Identifier: NCT00235092  
Health Authority: France: Institutional Ethical Committee

Study placed in the following topic categories:
Arterial Occlusive Diseases
Sirolimus
Heart Diseases
Clotrimazole
Myocardial Ischemia
Miconazole
Vascular Diseases
Tioconazole
Ischemia
Arteriosclerosis
Coronary Disease
Paclitaxel
Coronary Artery Disease

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Tubulin Modulators
Cardiovascular Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009