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Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)

NCT00233766 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-04-24

No results posted yet for this study

Summary

The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

Conditions

Interventions

DEVICE

Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • J. E. Sousa, MD · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-09-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Brazil

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 NCT00233766 on ClinicalTrials.gov