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

October 4, 2005
April 25, 2007
August 2003
Not Provided
The primary endpoint of the study is angiographic in-lesion binary restenosis rate at 8 months follow-up as determined by QCA.
Same as current
Complete list of historical versions of study NCT00235092 on ClinicalTrials.gov Archive Site
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The REALITY Study - Head-to-Head Comparison Between Cypher and Taxus
A Prospective, Randomized, Multi-Center Comparison of the Cypher Sirolimus-Eluting and the Taxus Paclitaxel-Eluting Stent Systems.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Cypher Sirolimus-Eluting Stent
  • Device: Taxus Paclitaxel-Eluting Stent
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1335
March 2006
Not Provided

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).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00235092
EC03-02
Yes
Not Provided
Cordis Corporation
Not Provided
Principal Investigator: Marie-Claude Morice, MD Institut Hospitalier Jacques Cartier
Cordis Corporation
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP