NCT05132361

SELUTION4SFA Trial

A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Efficacy of the SELUTION SLR™ 018 Drug Eluting Balloon in the Treatment of Subjects With Femoropopliteal Artery Lesions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: M.A. Med Alliance S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to demonstrate the safety and efficacy of the SELUTION SLR™ 018 DEB compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Detailed description

Prospective, multi-center, single blinded, 2:1 randomized, controlled, superiority clinical trial. This study will enroll up to 300 randomized subjects, and up to 20 subjects in a parallel pharmacokinetic (pK) sub study, at up to 60 clinical sites in the United Stated (US), Europe (EU) and Asia. A minimum of 50% of randomized subjects will be enrolled in the US. No more than 45 subjects (15% of the total randomized cohort) can be enrolled in the randomized cohort at any single investigational site. Randomized Cohort: Up to 300 subjects who meet all eligibility criteria will be randomized 2:1 by permuted block method (stratified by site and adjunctive lesion preparation) to one of two treatment arms: * Intervention - treatment with SELUTION SLR™ 018 DEB * Control - treatment with commercially available PTA (uncoated balloon) Pharmacokinetic (pK) Sub-study: The pK substudy is a parallel registry consisting of up to 20 additional consecutive subjects meeting all eligibility criteria treated with the SELUTION DEB recruited at select study sites. The separate PK substudy protocol details the schedule of evaluations and blood draws to characterize the pK plasma profile of sirolimus.

Conditions

• Peripheral Arterial Disease
• Superficial Femoral Artery Stenosis

Interventions

Type	Name	Description
DEVICE	SELUTION SLR™ 018 DEB	a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.
DEVICE	Plain (Uncoated) Balloon Angioplasty (PTA)	a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up above the-knee arteries that have been narrowed due to peripheral arterial disease.

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-06-24
• Completion: 2030-12-01
• First posted: 2021-11-24
• Last updated: 2026-01-12

Locations

38 sites across 4 countries: United States, Austria, Germany, Hong Kong

Regulatory

• FDA-regulated device study