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A Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent Systems (GENESIS)

NCT00322569 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2013-03-06

No results posted yet for this study

Summary

To demonstrate non-inferiority in 6-month angiographic in-stent late lumen loss of the pimecrolimus-eluting coronary stent (Corio) compared to the CoStar coronary stent control arm and the dual pimecrolimus/paclitaxel-eluting (Symbio) coronary stent compared to the CoStar coronary stent control arm for the treatment of single de novo lesions \<25 mm in length in native coronary arteries 2.5 - 3.5 mm in diameter.

Conditions

  • Coronary Disease

Interventions

DEVICE

Corio™ Pimecrolimus-Eluting Coronary Stent System

Drug-eluting stent

DEVICE

SymBio™ Pimecrolimus/Paclitaxel-Eluting Coronary Stent System

Drug-eluting stent

DEVICE

Costar ™ Paclitaxel-Eluting Coronary Stent System

Drug-eluting Stent

Sponsors & Collaborators

  • Conor Medsystems

    collaborator INDUSTRY

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Nicholas Curzen, M.D. · Southampton University Hospital

  • Stefan Verheye, M.D. · AZ Middelheim Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-10-31
Completion
2012-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00322569 on ClinicalTrials.gov