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CompletedNCT00235092Updated Apr 27, 2007

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

A Phase 4 interventional study of Cypher Sirolimus-Eluting Stent and Taxus Paclitaxel-Eluting Stent in Coronary Artery Disease, sponsored by Cordis Corporation. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-04-27.

Sponsored by Cordis Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
1,335
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 1,335 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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%;
  1. Totally occluded vessel (TIMI 0 level) (applies to both lesions);
  1. Prior stent within 10mm of target lesion (applies to both lesions).
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,335 participants

Interventions

  • DeviceCypher Sirolimus-Eluting Stent
  • DeviceTaxus Paclitaxel-Eluting Stent
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What researchers measure

Primary outcomes

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

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Study locations

1 site
  • Institut Hospitalier Jacques Cartier
    Massy, France
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References and documents

Publications

  • 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. PubMed 16493102 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00235092
Lead sponsor
Cordis Corporation
First posted
Oct 10, 2005
Start date
Aug 2003
Completion
Mar 2006
Last update
Apr 27, 2007

Study contacts

Marie-Claude Morice, MD
principal investigator · Institut Hospitalier Jacques Cartier

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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