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The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.

NCT00381420 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2008-10-31

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 VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY™ balloon-expandable stent. Both stents are mounted on the Raptor® Stent Delivery Systems.

The secondary objective is to assess cost-effectiveness expressed in incremental cost/life year gained or cost/quality adjusted life year gained at different time points (8 months, 1 year, 3 and 5 years).

Conditions

Interventions

DEVICE

drug-eluting stent

sirolimus-coated Bx VELOCITY Balloon-Expandable Stent

DEVICE

bare-metal stent

un-coated Bx VELOCITY Stent

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Erick Schampaert, MD · Hopital Sacreé-Coeur, Montréal, Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-03-31
Primary Completion
2002-12-31
Completion
2008-06-30

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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 NCT00381420 on ClinicalTrials.gov