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Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions — PESTO-AFC  

Peripheral Artery Disease Clinical Trial

Official title:
Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions A Prospective, Multi-centre, Randomised Study

Clinical Trial 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.

Clinical Trial Description

Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02517827
Study type Interventional
Source Herz-Zentrums Bad Krozingen
Contact Aljoscha Rastan, MD
Phone 004976334024913
Email aljoscha.rastan@universitaets-herzzentrum.de
Status Recruiting
Phase N/A
Start date August 1, 2017
Completion date December 2021
View Details
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