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Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia

NCT02563535 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-01-22

No results posted yet for this study

Summary

The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.

Conditions

Interventions

DEVICE

DEB

angioplasty with Litos drug eluting balloon

DEVICE

PTA

angioplasty with conventional balloon

Sponsors & Collaborators

  • Ospedale San Donato

    lead OTHER

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
2020-01-31
Completion
2020-01-31

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 NCT02563535 on ClinicalTrials.gov