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FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

NCT01960647 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2013-10-10

No results posted yet for this study

Summary

The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

Conditions

Interventions

DEVICE

Percutaneous transluminal angioplasty with uncoated balloon

DEVICE

Percutaneous transluminal angioplasty with Paclitaxel balloon

Sponsors & Collaborators

  • Eurocor GmbH

    lead INDUSTRY

Principal Investigators

  • Karl-Ludwig Schulte, Prof. PhD · Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-09-30

Countries

  • Austria
  • Colombia
  • Germany
  • Hungary
  • Italy
  • Spain

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 NCT01960647 on ClinicalTrials.gov