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Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE-RACE Study)

NCT00130546 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2009-05-15

No results posted yet for this study

Summary

The main objective of this study is to assess the safety and effectiveness of the Sirolimus eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting with two or more coronary artery stenoses (prospective, randomized, intra-individual comparison).

Conditions

Interventions

DEVICE

Paclitaxel-eluting TAXUS(TM)

TAXUS(TM) Paclitaxel-eluting stent

DEVICE

Sirolimus eluting Cypher Select(TM)

Sirolimus eluting Cypher Select(TM) stent

Sponsors & Collaborators

  • Cordis Medizinische Apparate GmbH

    collaborator OTHER

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Manfred Zehender, MD PhD · University Clinic Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT00130546 on ClinicalTrials.gov