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Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

NCT02279784 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2014-11-03

No results posted yet for this study

Summary

The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Conditions

Interventions

DEVICE

Freeway PTA

angioplasty with Freeway drug-eluting balloon

DEVICE

Lutonix PTA

angioplasty with Lutonix drug-eluting balloon

Sponsors & Collaborators

  • Ospedale San Donato

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2016-10-31

Countries

  • Italy

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 NCT02279784 on ClinicalTrials.gov