SELUTION4SFA Trial

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Peripheral Arterial Disease, Superficial Femoral Artery Stenosis

Intervention / Treatment
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* Device: SELUTION SLR™ 018 DEB
* Device: Plain (Uncoated) Balloon Angioplasty (PTA)


Participation Criteria
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Eligibility Criteria
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Clinical Inclusion Criteria: Subject age is ≥ 18 years or minimum legal age as required by local regulations. Life expectancy >1 year in opinion of investigator. Documented ischemia with Rutherford classification category 2, 3 or 4. Target lesion(s) in the SFA or PPA. Able to walk without the assistance of a walker. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment. 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. Clinical Exclusion Criteria: Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography. Inability to tolerate dual antiplatelet therapy. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated. Stroke or MI within 3 months of enrollment. Symptom onset less than 14 days prior to index procedure (acute limb ischemia). Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease) Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device). Subject has target lesion(s) that require treatment via pedal site. Subject has target lesion(s) that require access via upper extremity arteries. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter. Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure). Systemic infection (WBC > 12,000 and febrile) or known immune compromise. Breast-feeding woman. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. Angiographic Exclusion Criteria: Presence of a previously placed stent in the treated artery. Failure to successfully cross the target lesion. Residual stenosis ≥30% after pre-dilatation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SELUTION SLR™ 018 DEB<br>Treatment with Selution SLR drug eluting balloon to apply long term (>90 days) local treatment with sirolimus | Device: SELUTION SLR™ 018 DEB<br>* 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.<br>|
| Active Comparator: Plain (Uncoated) Balloon Angioplasty (PTA)<br>Opening artery only by dilatation with an temporary inserted and inflated balloon. | Device: Plain (Uncoated) Balloon Angioplasty (PTA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency of the target lesion at 12 months post-index procedure |  | 12 months | 
| Freedom from death (device and procedure related) through 30 days post-index procedure |  | 30 days | 
| Freedom from target limb above-ankle amputation and clinically-driven target lesion revascularization (CD-TLR) at 12 months. |  | 12 months |