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A Randomized, Double-blind Study to Assess Paclitaxel-eluting Stents in Treatment of Longer Lesions

NCT00297804 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2017-04-21

No results posted yet for this study

Summary

The clinical investigation is an international, prospective, multi-center, double-blind, randomized safety and efficacy trial. The purpose of this study is to evaluate the safety and effectiveness of the TAXUS(TM)Stent System with 1µg/mm2 (loaded drug/stent surface area) of paclitaxel incorporated into a moderate rate-release formulation of triblock copolymer carrier system in patients with a higher risk of target lesion revascularisation and restenosis.

Conditions

Interventions

DEVICE

TAXUS Express Paclitaxel-Eluting Coronary Stent System

Paclitaxel-Eluting Coronary Stent System

DEVICE

Control stent

control stent

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Eberhard Grube, MD · HELIOS Clinic Siegburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-05-31
Primary Completion
2003-10-31
Completion
2008-02-29

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 NCT00297804 on ClinicalTrials.gov