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Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

NCT00987324 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2016-11-21

No results posted yet for this study

Summary

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

Conditions

Interventions

DEVICE

Taxus stent

Implantation of paclitaxel-eluting stent

DEVICE

SeQuent Please

Dilation with SeQuent Please (paclitaxel-eluting balloon)

DEVICE

Conventional Balloon Catheter

Ryuijin, Trek

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Julinda Mehilli, MD · Deutsches Herzzentrum Munich

  • Adnan Kastrati, MD · Deutsches Herzzentrum

  • Klaus Tiroch, MD · Deutsches Herzzentrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2012-07-31
Completion
2013-10-31

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 NCT00987324 on ClinicalTrials.gov