Ignite Creation Date:
2025-12-17 @ 1:42 PM
Ignite Modification Date:
2025-12-23 @ 9:50 PM
Study NCT ID:
NCT05132361
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2021-11-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SELUTION4SFA Trial
Sponsor:
M.A. Med Alliance S.A.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: