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Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

NCT02212470 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-06-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

Conditions

  • Peripheral Arterial Disease
  • Arterial Occlusive Diseases
  • Atherosclerosis
  • Arteriosclerosis
  • Cardiovascular Diseases
  • Peripheral Vascular Diseases
  • Paclitaxel
  • Plaque, Atherosclerotic
  • Critical Limb Ischemia

Interventions

DEVICE

Drug Eluting Balloon Angioplasty

Angioplasty with Drug eluting balloon after pre dilatation

DEVICE

Nitinol stenting

Nitinol stent deployment

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Instituto Dante Pazzanese de Cardiologia

    lead OTHER

Principal Investigators

  • BRUNO L ALMEIDA, MD · Instituto Dante Pazzanese de Cardiologia

  • FABIO H ROSSI, MD, PHD · Instituto Dante Pazzanese de Cardiologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-12-31
Completion
2019-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02212470 on ClinicalTrials.gov