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Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease

NCT02710656 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2020-01-23

No results posted yet for this study

Summary

A randomized multicentric study for endovascular treatment of patients with obstructive disease in the SFA (superficial femoral artery) and in the popliteal artery.

Conditions

Interventions

DEVICE

Legflow® balloon

Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel

DEVICE

Standard PTA

Percutaneous angioplasty performed with a standard balloon

Sponsors & Collaborators

  • Archer Research

    collaborator INDUSTRY

  • Cardionovum GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Goverde, Dr. · ZNA Stuivenberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-10-31
Completion
2019-11-30

Countries

  • Belgium
  • France
  • Germany

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 NCT02710656 on ClinicalTrials.gov