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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
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).

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00235092
EC03-02
Yes
Not Provided
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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