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Drug Eluting Balloon in peripherAl inTErvention SFA

NCT01556542 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2013-01-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

DEVICE

nitinol stent implantation

nitinol stent implantation

Sponsors & Collaborators

  • Leonardo Bolognese, MD

    lead OTHER

Principal Investigators

  • Francesco Liistro, MD · Cardiovascular Department, San Donato Hospital, Arezzo, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-09-30

Countries

  • Italy

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 NCT01556542 on ClinicalTrials.gov