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Trial of a Novel Paclitaxel-coated Balloon With Citrate Excipient for Restenosis in -Limus Analogue DES

NCT02367495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2019-01-08

No results posted yet for this study

Summary

Hypothesis:

Angioplasty with a novel paclitaxel-coated balloon (PCB; Agent, Boston Scientific) with citrate-based excipient will be non-inferior to conventional paclitaxel-coated balloon with iopromide excipient (PCB) for the treatment of coronary restenosis after implantation of limus-analogue drug-eluting stents (DES)

Conditions

  • Coronary Restenosis

Interventions

DEVICE

PCB

PCB with Citrate-based excipient

Sponsors & Collaborators

  • Deutsches Herzzentrum Muenchen

    lead OTHER

Principal Investigators

  • Robert Byrne, MB BCh PhD · Deutsches Herzzentrum Muenchen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-10-25
Completion
2017-10-25

Countries

  • Germany

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 NCT02367495 on ClinicalTrials.gov