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Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study

NCT03023098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2017-01-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.

Conditions

  • Peripheral Artery Occlusive Disease
  • Peripheral Artery Restenosis
  • Peripheral Artery Stenosis

Interventions

DEVICE

Conventional PTA

After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon

DEVICE

Drug-eluting balloon

After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon

Sponsors & Collaborators

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Maarit Venermo, M.D., Ph.D. · Helsinki University Hospital, Dept. of Vascular Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Finland

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 NCT03023098 on ClinicalTrials.gov