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Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)

NCT00231257 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2009-11-19

No results posted yet for this study

Summary

The main objective of this study is to demonstrate the superiority or non-inferiority of the sirolimus-eluting Bx VELOCITY® stent compared to intravascular brachytherapy in patients with in-stent restenotic native coronary artery lesions.

Conditions

  • In-Stent Restenosis

Interventions

DEVICE

Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent

Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent

PROCEDURE

Brachytherapy

Brachytherapy

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • David R. Holmes, Jr., MD · Mayo Clinic - Rochester, Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2005-01-31
Completion
2009-09-30

Countries

  • United States

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 NCT00231257 on ClinicalTrials.gov