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Study of Sirolimus-Coated BX VELOCITY Balloon-Expandable Stent in Treatment of de Novo Native Coronary Artery Lesions (SIRIUS)

NCT00232765 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1058

Last updated 2009-09-16

No results posted yet for this study

Summary

The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITYTM stent in reducing target vessel failure in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITYTM balloon-expandable stent. Both stents are mounted on the Raptorâ over-the-wire (OTW) Stent Delivery System.

Conditions

Interventions

DEVICE

CYPHER Sirolimus-Eluting Stent

CYPHER Sirolimus-Eluting Stent

DEVICE

Uncoated BX VELOCITY Balloon-Expandable Stent

Uncoated BX VELOCITY Balloon-Expandable Stent

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Martin B. Leon, MD · New York Presbyterian Hospital/Columbia University Medical Center

  • Jeffrey Moses, MD · New York Presbyterian Hospital/Columbia University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2002-05-31
Completion
2008-11-30

Countries

  • United States

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 NCT00232765 on ClinicalTrials.gov