MedTrace Logo

Drug Eluting Balloons PTA in Infra-popliteal Arteries in Patients With Critical Limb Ischemia

NCT02498080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-15

No results posted yet for this study

Summary

Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage. During the last decade, drug eluting balloons (DEB) were found to be an effective tool for the treatment of atherosclerotic disease in several arterial districts. Aim of this study is to compare results of DEB PTA versus standard PTA of infra-popliteal district in patients with CLI, from a single-centre prospective randomized trial.

Conditions

  • Critical Limb Ischemia

Interventions

PROCEDURE

DEB PTA

paclitaxel drug eluting balloon PTA

PROCEDURE

Standard PTA

Standard PTA

Sponsors & Collaborators

  • Neuromed IRCCS

    lead OTHER

Principal Investigators

  • Antonella Biello, MD · Neuromed IRCCS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-09-30
Completion
2018-09-30

More Related Trials

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 NCT02498080 on ClinicalTrials.gov