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Drug-eluting Balloon in Bifurcations Trial

NCT00857441 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-07-20

No results posted yet for this study

Summary

The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:

1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement).
2. Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.

Conditions

Interventions

DEVICE

Drug eluting balloon

Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel

DEVICE

Liberté

Bare metal stent

DEVICE

PTCA balloon catheter

Percutaneous transluminal coronary angioplasty catheter

DEVICE

Taxus

Paclitaxel eluting stent

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Pieter Stella, MD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-09-30
Completion
2015-01-31

Countries

  • Belgium
  • Netherlands

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 NCT00857441 on ClinicalTrials.gov