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Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions

NCT02517827 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2018-08-03

No results posted yet for this study

Summary

The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended.

The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.

Conditions

Interventions

DEVICE

Atherectomy and paclitaxel-coated balloon angioplasty

Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery

PROCEDURE

Open, surgical endarterectomy

open, surgical endarterectomy of the common femoral artery

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Herz-Zentrums Bad Krozingen

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-12-31
Completion
2021-12-31

Countries

  • Germany

Study Locations

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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 NCT02517827 on ClinicalTrials.gov