SELUTION4SFA Trial

NCT05132361 | Active Not Recruiting FDA Device

• 1 other identifier: S2020-02
• Study Type: interventional
• Target: 300
• Locations: 4 countries
• Sites: 38

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).

Conditions

Peripheral Arterial Disease; Superficial Femoral Artery Stenosis

Outcome Measures

Primary Outcomes (6)

• Primary Efficacy Endpoint

  Primary patency of the target lesion defined as freedom from ANY of the following adverse events: * Clinically driven target lesion revascularization (CD-TLR, defined as re-intervention of target lesion(s) due to recurrent, persistent, or worsening symptoms and angiographic restenosis (≥ 50% diameter stenosis) of target lesion by ACL measurement) OR * Restenosis as determined by core lab adjudicated duplex ultrasound peak systolic velocity ratio of \>2.4 or occlusion of the target lesion.

  12 months

• Primary Safety Endpoint

  The primary safety endpoint is the freedom from ANY of the following adverse events: * All-cause perioperative death (POD) \[evaluated at 30 days\] OR * Target limb major (above-the-ankle) amputation \[evaluated at 12 months\] OR * Clinically driven target lesion revascularization (CD-TLR) \[evaluated at 12 months\]

  30 days or 12 months

• PK Sub-Study Primary Endpoint: C(max)

  PK parameters of C(max).

  6 months

• PK Sub-Study Primary Endpoint: T(max)

  PK parameters of T(max).

  6 months

• PK Sub-Study Primary Endpoint: AUC(last)

  PK parameters of AUC(last).

  6 months

• PK Sub-Study Primary Endpoint MRT(last)

  PK parameters of Mean Residence Time(last).

  6 months

Secondary Outcomes (29)

• Powered Secondary Endpoints

  12 months

• Device success

  Immediately following the procedure

• Procedural (technical) success

  Immediately following the procedure

• Clinical success

  Discharge defined as immediately prior to hospital discharge from the index procedure or within 7 days, whichever occurs first

• Secondary Safety Endpoints

  1, 6, and 12 months, and 2-5 years

Study Arms (2)

SELUTION SLR™ 018 DEB

EXPERIMENTAL

Treatment with Selution SLR drug eluting balloon to apply long term (\>90 days) local treatment with sirolimus

Device: SELUTION SLR™ 018 DEB

Plain (Uncoated) Balloon Angioplasty (PTA)

ACTIVE COMPARATOR

Opening artery only by dilatation with an temporary inserted and inflated balloon.

Device: Plain (Uncoated) Balloon Angioplasty (PTA)

Interventions

SELUTION SLR™ 018 DEB DEVICE

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.

SELUTION SLR™ 018 DEB

Plain (Uncoated) Balloon Angioplasty (PTA) DEVICE

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.

Plain (Uncoated) Balloon Angioplasty (PTA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.A. Med Alliance S.A.: lead
• NAMSA: collaborator
• Cordis US Corp.: collaborator

Study Sites (38)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

St. Helena Hospital

St. Helena, California, 94558, United States

Location

ClinRé

Thornton, Colorado, 80023, United States

Location

Vascular Care Group

Darien, Connecticut, 06820, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, 34205, United States

Location

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32218, United States

Location

Palm Vascular Centers

Miami Beach, Florida, 33140, United States

Location

Guardian Research Organization, LLC

Winter Park, Florida, 32792, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792, United States

Location

Heart Care Centers Research Foundation

Palos Park, Illinois, 60464, United States

Location

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Cardiovascular Institute of the South

Gray, Louisiana, 70359, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Mercy Hospital

St Louis, Missouri, 63128, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388, United States

Location

El Paso Cardiology

El Paso, Texas, 79902, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Texas Cardiac and Vascular Institute San Antonio

San Antonio, Texas, 78229, United States

Location

Universitätsklinikum Graz

Graz, A-8036, Austria

Location

Alexianer Klinikum Hochsauerland

Arnsberg, 59759, Germany

Location

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Krankenhaus Buchholz

Buchholz, 21244, Germany

Location

Sana Kliniken Oberfranken Coburg

Coburg, 96450, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

University Clinic Tübingen

Tübingen, 72076, Germany

Location

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

Location

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The physician performing the index procedure as well as study site personnel present at the index procedure will not be blinded, however, every effort will be made to maintain blinding for the following: * Subjects and their families * Site personnel only involved in conducting study assessments during follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: December 1, 2022
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 12, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (28); AU (1); DE (7); HK (2)