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Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)

NCT01485068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2015-04-08

No results posted yet for this study

Summary

The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.

Conditions

  • In-stent Coronary Artery Restenosis

Interventions

DEVICE

Danubio paclitaxel-eluting balloon

Inflation of the Danubio Paclitaxel Eluting Balloon in in-stent restenosis lesions.

Sponsors & Collaborators

  • European Cardiovascular Research Center

    collaborator NETWORK

  • MINVASYS

    lead INDUSTRY

Principal Investigators

  • Jacques BERLAND, MD · Clinique Saint Hilaire - ROUEN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2013-07-31
Completion
2014-07-31

Countries

  • France

Study Locations

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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 NCT01485068 on ClinicalTrials.gov