NCT03776799

BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery

BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding (study Arm) Versus Stent-preferred (control Arm) Approach Within a Prospective, Randomized, Multi-center Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Leipzig · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis \>10cm, occlusions \>5cm).

Detailed description

Prospective, multi-center 1:1 randomized Study. Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm) In total 120 patient will be enrolled in this study, each strata will include 60 patients. All enrolled patients will be followed up for 24 month to asses the incidence of restenosis by duplex ultrasound and major adverse events. Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36, 48 and 60 month.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Stent-avoiding	Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
DEVICE	Stent-based	Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-08-24
• Completion: 2026-07-01
• First posted: 2018-12-17
• Last updated: 2024-12-09

Locations

1 site across 1 country: Germany