NCT02517827

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (estimated)
• Sponsor: Herz-Zentrums Bad Krozingen · Academic / Other
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Peripheral Artery Disease
• Artery Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-12-01
• Completion: 2021-12-01
• First posted: 2015-08-07
• Last updated: 2018-08-03

Locations

1 site across 1 country: Germany