SELUTION4BTK Trial

NCT05055297 | Recruiting DMC FDA Device

• 1 other identifier: S2021-01
• Study Type: interventional
• Target: 376
• Locations: 10 countries
• Sites: 48

Brief Summary

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Conditions

Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary Efficacy Endpoint

  Hierarchical composite efficacy endpoint determined by pair-wise comparisons among all subjects (Win Ratio method) according to the following pre-specified hierarchy of adverse outcomes: * Major (above-the-ankle) amputation * CD-TLR * Target lesion occlusion by angiography (if angiography is not available, the decision will be made on a secondary modality, in order of preference: computed tomography angiogram \[CTA\], magnetic resonance angiography \[MRA\] or DUS) * Transverse View Area Loss (TVAL%) by angiography.

  6 months

• Primary Safety Endpoint

  Freedom from the composite of MALE and all-cause perioperative death (POD). MALE is defined as major (above-the-ankle) amputation or major reintervention (new bypass graft, jump/ interposition graft revision, thrombectomy/thrombolysis) of the index limb.

  30 days

Secondary Outcomes (20)

• Primary sustained clinical improvement

  1, 6, 12, 24, and 36 months

• Secondary sustained clinical improvement

  1, 6, 12, 24, and 36 months

• Major amputation

  1, 6, 12, 24, and 36 months

• Amputation-free survival

  1, 6, 12, 24, and 36 months

• Primary assisted patency

  1, 6, 12, 24, and 36 months

Study Arms (2)

SELUTION SLR™ DEB 014

EXPERIMENTAL

Device: SELUTION SLR™ DEB 014

Plain (Uncoated) Balloon Angioplasty (PTA)

ACTIVE COMPARATOR

Device: Plain (Uncoated) Balloon Angioplasty (PTA)

Interventions

SELUTION SLR™ DEB 014 DEVICE

a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

SELUTION SLR™ DEB 014

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 peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

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 older depending on local regulations.
• Subject life expectancy is ≥ 1 year.
• Subject has documented chronic limb-threatening ischemia in the target limb with Rutherford classification category 4 or 5 and symptoms of \> 2 weeks duration.
• Subject is willing and able to provide written informed consent and comply with study procedures and required follow-up evaluations.
• Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.
• Subjects must meet all the following criteria to be enrolled in the trial:
• Target lesion(s) must be de novo or non-stented restenotic lesion(s) located within the BTK arteries distal to the tibial plateau and above the tibiotalar joint line. BTK arteries include the P3 segment of the popliteal artery, the tibio-peroneal trunk, peroneal artery, anterior tibial artery, and posterior tibial artery.
• BTK Target lesions cannot be contiguous with inflow lesions and at least 3 cm of normal artery should extend beyond the tibial plateau to ensure there is no overlap.
• Target lesions must have a diameter stenosis of ≥ 70% (including total occlusions) by visual estimate and must be indicated for PTA treatment.
• Target vessel reference diameter(s) are ≥ 2mm and ≤ 4mm. Note: the SELUTION SLR 014 DEB and the control PTA balloon size cannot exceed 4.0 mm.
• Target lesions must be confined to a single target vessel. NOTE: Subjects with other non-target BTK lesions in separate non-target vessels may be enrolled, provided that the non-target lesions have been successfully treated (residual stenosis ≤ 30% with no distal embolization or flow limiting ≥ Grade C dissection). NOTE: Any adjunctive therapies are permitted for the treatment of non-target BTK lesions, but no DEB or DES may be used.
• Any target lesion must be ≥ 30 mm in length and the total combined length of all target lesions must be ≤ 140 mm (total treatment length ≤ 150 mm allowing for 5 mm proximal and distal shoulder treatment). Note: All target lesions and all inflow lesions must be treatable by one or more SELUTION SLR 014/018 DEB(s) such that the total planned per-subject drug dose (calculated by summing the drug dose of all individual planned balloon sizes) would be ≤ 7069 μg. Note: A total treated segment length of ≤ 150 mm for BTK and ≤ 200 mm for inflow segment is acceptable irrespective of DEB balloon diameter.
• The tibial and pedal runoff distal to the target lesions must be patent OR the target vessel(s) must reconstitute above the ankle or display normal terminal branching as follows:
• If the target vessel is the P3 segment, any 1 of the 3 distal arteries must show a patent (≤ 50% stenosis by visual estimate) outflow.
• If the target vessel is the peroneal artery, the artery must demonstrate normal terminal branching.

You may not qualify if:

• Subjects will be excluded if any of the following criteria apply:
• Subject has extensive tissue loss (Rutherford category 6) extending above the trans metatarsal level, salvageable only with complex foot reconstruction or non-traditional trans metatarsal amputations. This includes subjects with:
• Osteomyelitis involving proximal to the metatarsal head(s)
• Any heel wound or wound with calcaneal bone involvement
• d) Wounds that would require flap coverage or complex wound management for large soft tissue defect e) Full-thickness wounds on the dorsum of the foot with exposed tendon or bone
• Subject has chronic renal insufficiency (dialysis dependent, or glomerular filtration rate \[GFR\] ≤ 30 ml/min/1.73 m2 within 30 days of index procedure) or has undergone renal transplantation.
• Subject has acute renal insufficiency confirmed by 50% increase of serum creatinine within 48 hours before procedure and/or decrease in urine output.
• Subject has acute limb ischemia with onset of index limb symptoms less than 2 weeks prior to index procedure.
• Subjects has wounds that are deemed to be neuropathic or non-ischemic in nature or any venous or mixed wounds.
• Subject has had prior major amputation of the ipsilateral extremity or planned major amputation of either leg.
• Target limb iliac or common femoral artery bypass within 6 weeks of index procedure.
• Prior (within 14 days) or planned (within 30 days) surgical or endovascular procedures. The following procedures are permitted:
• Contralateral limb iliac artery treatment
• Diagnostic angiography
• Foot wound debridement

Sponsors & Collaborators

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

Study Sites (48)

Chandler Regional Medical Center

Chandler, Arizona, 85297, United States

RECRUITING

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

RECRUITING

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

TERMINATED

St. Helena Hospital

St. Helena, California, 94574, United States

TERMINATED

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

ClinRé

Thornton, Colorado, 80023, United States

TERMINATED

Vascular Care Group

Darien, Connecticut, 06820, United States

RECRUITING

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

RECRUITING

Palm Vascular Centers

Miami, Florida, 33141, United States

RECRUITING

Guardian Research Organization, LLC

Winter Park, Florida, 32792, United States

RECRUITING

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, 31792, United States

TERMINATED

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

RECRUITING

Cardiovascular Institute of the South

Gray, Louisiana, 70359, United States

RECRUITING

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

RECRUITING

Beth Israel Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

Sorin Medical Group

New York, New York, 10005, United States

RECRUITING

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Hightower Clinical Research

Oklahoma City, Oklahoma, 73134, United States

RECRUITING

Miriam Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, 37388, United States

SUSPENDED

El Paso Cardiology

El Paso, Texas, 79912, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Texas Cardiac and Vascular Institute San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Christus Health

Tyler, Texas, 75702, United States

RECRUITING

LKH-Universitätsklinikum Graz

Graz, A-8036, Austria

RECRUITING

Ambroise Paré Hospital

Boulogne-Billancourt, 92100, France

RECRUITING

Hôpital St. Joseph

Paris, 75014, France

RECRUITING

Alexianer Klinikum Hochsauerland

Arnsberg, 59759, Germany

RECRUITING

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

RECRUITING

Krankenhaus Buchholz

Buchholz, 21244, Germany

RECRUITING

Sana Kliniken Oberfranken Coburg

Coburg, 96450, Germany

RECRUITING

University of Essen

Essen, 45147, Germany

RECRUITING

Universitatsklinikum Tubingen

Tübingen, Germany

RECRUITING

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

RECRUITING

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

RECRUITING

Ospedale Pederzoli

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

UGC - Maria Cecilia Hospital

Cotignola, 48033, Italy

RECRUITING

Ospedale Policlinico San Martino

Genova, 16132, Italy

TERMINATED

St. Antonius Hospital

Nieuwegein, 3435 CM, Netherlands

RECRUITING

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Singapore General Hospital

Singapore, 169856, Singapore

RECRUITING

Inselspital Bern

Bern, Switzerland

TERMINATED

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

Central Study Contacts

Kara Piscani

CONTACT

+14846805857; kara.piscani@cordis.com

Tamarah Suys

CONTACT

+41788957756; tamarah.suys@cordis.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: May 19, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 30, 2032
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (1); DE (6); NL (1); IT (3); CH (1); FR (2); US (30); HK (2); SG (1)