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DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.

NCT01127958 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2017-02-17

No results posted yet for this study

Summary

The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.

Conditions

  • In-stent Restenosis

Interventions

DEVICE

PCI with a drug-eluting balloon

PCI with a drug-eluting balloon for in-stent restenosis

DEVICE

PCI with a drug-eluting stent

PCI with a drug-eluting stent for in-stent restenosis

Sponsors & Collaborators

  • B. Braun Medical B.V.

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Jan Baan, Dr · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Netherlands

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 NCT01127958 on ClinicalTrials.gov