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Local Paclitaxel or Balloon Angioplasty Below the Knee

NCT03149913 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-05-11

No results posted yet for this study

Summary

Patients with claudication or critical limb ischemia will be treated either with uncoated balloons or paclitaxel coated balloons in order to enhance the vessel patency in stenosed or occluded below the knee arteries

Conditions

  • Stenosis
  • Occlusion
  • Restenosis

Interventions

DEVICE

SequentPlease OTW paclitaxel coated balloon catheter

PTA with SequentPlease OTW paclitaxel coated balloon catheter

DEVICE

conventional uncoated balloon for BTK endovascular therapy

PTA with uncoated balloon for BTK endovascular therapy

Sponsors & Collaborators

  • InnoRa GmbH

    collaborator INDUSTRY

  • Prof. Dr. med. Gunnar Tepe

    lead OTHER

Principal Investigators

  • Gunnar Tepe, MD · RoMed Klinikum Rosenheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-15
Primary Completion
2018-12-30
Completion
2020-07-31

Countries

  • Austria
  • 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 NCT03149913 on ClinicalTrials.gov