MedTrace Logo

The Study of the BX VELOCITY Stent In Patients With De Novo Coronary Artery Lesions.

NCT00235144 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2009-05-11

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® Rapid Exchange Stent Delivery System.

Conditions

Interventions

DEVICE

sirolimus-coated Bx Velocity stent

drug-eluting stent

DEVICE

uncoated Bx Velocity stent

bare-metal stent

Sponsors & Collaborators

  • Cordis Corporation

    lead INDUSTRY

Principal Investigators

  • Joachim Schofer, MD · Herzkatheterlabor und Praxisklinik, Hamburg

  • Günter Breithardt, MD · Med. Klinik und Poliklinik, Münster

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
2002-10-31
Completion
2008-09-30

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 NCT00235144 on ClinicalTrials.gov