Tennessee Center for Clinical Trials | Tullahoma, TN
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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).
Full 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:
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.
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Inclusion and exclusion criteria
Clinical Inclusion Criteria:
Angiographic Inclusion Criteria:
Angiographic evidence that target lesion lies within the superficial femoral artery and/or proximal popliteal artery (P1 and P2 only).
Angiographic evidence that the target lesion consists of either a de novo lesion or a non-stented restenotic lesion, or a combination of both, that meets one of the following criteria:
A. A stenosis of 70-99% with lesion length between ≥3cm and <20cm by visual estimation.
B. A total (100%) occlusion with lesion length between ≥3cm and ≤10cm by visual estimation.
C. A combination lesion (stenosis and total occlusion) must have a total lesion length between ≥3cm and <20cm by visual estimation with an occluded segment that is ≤10cm by visual estimation.
D. If multiple lesions are to be treated, then only 2 lesions may be included. The total combination of lengths must be between ≥3cm and < 20cm by visual estimation, and there must be at least 5 cm of artery that is not to be treated between them.
Target vessel reference diameter ≥4mm and ≤7mm.
Patent arterial inflow (common iliac, external iliac, common femoral and profunda femoris arteries, and the proximal 2 cm of the SFA) free from significant lesion (defined as ≥50% stenosis) as confirmed on angiography.
Note: Where required, inflow iliac arteries (common and external iliac arteries only) must be successfully treated during the index procedure. Completion angiography must confirm successful treatment of inflow disease (≤30% residual stenosis, no distal embolization, and no Grade C or greater dissection ) prior to pre-dilation and randomization of the target lesion(s). Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries.
Angiographic evidence of adequate distal run off (defined as ≤50% stenosis) in one or more tibial arteries on initial angiography, and if applicable, after completion of inflow artery treatment.
Note: Treatment of outflow disease is permitted during the index procedure. Drug-eluting devices are not allowed for outflow treatment.
PK Sub-Study Inclusion Criteria:
Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria:
Clinical Exclusion Criteria:
Angiographic Exclusion Criteria:
PK Sub-Study Exclusion Criteria:
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
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Central trial contact
Tamarah Suys; Anna Hubert
Data sourced from clinicaltrials.gov
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