Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05055297

SELUTION4BTK Trial

Led by M.A. Med Alliance S.A. · Updated on 2026-04-28

376

Participants Needed

48

Research Sites

532 weeks

Total Duration

On this page

Sponsors

M

M.A. Med Alliance S.A.

Lead Sponsor

N

NAMSA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

SELUTION4BTK Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Life expectancy of at least 1 year
  • Documented chronic limb-threatening ischemia in the target limb with Rutherford category 4 or 5 and symptoms lasting more than 2 weeks
  • Able and willing to give written informed consent and comply with study procedures and follow-up
  • Female participants of childbearing potential must be non-breastfeeding and have a negative pregnancy test within 7 days before the procedure
  • Target lesion(s) must be new or non-stented restenotic lesions located in below-the-knee arteries distal to the tibial plateau and above the tibiotalar joint
  • Target lesions must have at least 70% diameter narrowing by visual estimate and be suitable for balloon angioplasty treatment
  • Target vessel diameter between 2mm and 4mm, with balloon size not exceeding 4.0 mm
  • Target lesions confined to a single vessel; other non-target lesions must be successfully treated
  • Target lesion length at least 30 mm and total treatment length no more than 150 mm
  • Distal runoff vessels must be patent or reconstituted as specified for each artery
  • No significant inflow vessel disease or successfully treated inflow disease
  • Successful lesion preparation with less than or equal to 30% residual narrowing and no flow-limiting dissection before randomization
Not Eligible

You will not qualify if you...

  • Extensive tissue loss (Rutherford category 6) above the trans metatarsal level requiring complex foot reconstruction
  • Chronic renal insufficiency with dialysis dependence or GFR less than or equal to 30 ml/min/1.73 m2 within 30 days or previous renal transplant
  • Acute renal insufficiency within 48 hours before procedure
  • Acute limb ischemia with symptoms less than 2 weeks prior
  • Neuropathic, non-ischemic, venous, or mixed wounds
  • Prior major amputation or planned major amputation of the target or either leg
  • Target limb iliac or common femoral artery bypass within 6 weeks
  • Recent or planned surgical or endovascular procedures within specified time frames except permitted procedures
  • Prior treatment of target lesion with drug-coated balloon within 1 year or any prior stent treatment unless lesion is far from stent and low stenosis
  • Target lesions requiring alternative therapies like thrombolysis or stenting
  • Treatment via pedal or upper extremity access
  • Recent non-coronary artery treatment with drug-coated devices within 3 months
  • Known allergy to Sirolimus or required pharmacologic agents
  • Contraindication to antiplatelet therapy
  • Recent disabling stroke or heart attack within 3 months
  • Acute coronary syndrome (stabilized allowed)
  • Non-atherosclerotic disease of the target vessel
  • Hypercoagulable disorders or low platelet count
  • Systemic infection with fever and high white blood count
  • Known immune compromise or immunosuppressive therapy (except topical corticosteroids)
  • Current or planned cancer treatment or metastatic cancer (local creams allowed)
  • New York Heart Association class IV heart failure
  • Bedridden status
  • Body mass index under 18
  • Participation in another ongoing investigational drug or device study
  • Other conditions limiting study participation or follow-up
  • Presence of previously placed stent in target vessel unless lesion is distant and low stenosis
  • Significant inflow disease in common femoral or profunda femoris arteries
  • Unsuccessful lesion pre-dilatation
  • Presence of intra-arterial thrombus or embolism
  • Need for treatment of arteries below the tibiotalar joint or pedal arteries; angioplasty below this joint not permitted

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 48 locations

1

Chandler Regional Medical Center

Chandler, Arizona, United States, 85297

Actively Recruiting

2

St. Bernards Medical Center

Jonesboro, Arkansas, United States, 72401

Actively Recruiting

3

Arkansas Heart Hospital

Little Rock, Arkansas, United States, 72211

Terminated

4

St. Helena Hospital

St. Helena, California, United States, 94574

Terminated

5

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, United States, 90502

Actively Recruiting

6

ClinRé

Thornton, Colorado, United States, 80023

Terminated

7

Vascular Care Group

Darien, Connecticut, United States, 06820

Actively Recruiting

8

Yale University

New Haven, Connecticut, United States, 06519

Actively Recruiting

9

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, United States, 32605

Actively Recruiting

10

Palm Vascular Centers

Miami, Florida, United States, 33141

Actively Recruiting

11

Guardian Research Organization, LLC

Winter Park, Florida, United States, 32792

Actively Recruiting

12

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, United States, 31792

Terminated

13

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

14

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States, 60068

Actively Recruiting

15

Cardiovascular Institute of the South

Gray, Louisiana, United States, 70359

Actively Recruiting

16

MedStar Health Research Institute

Hyattsville, Maryland, United States, 20782

Actively Recruiting

17

Beth Israel Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

18

University of Massachusetts Medical Center

Worcester, Massachusetts, United States, 01655

Actively Recruiting

19

Sorin Medical Group

New York, New York, United States, 10005

Actively Recruiting

20

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, United States, 27607

Actively Recruiting

21

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

22

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

23

Hightower Clinical Research

Oklahoma City, Oklahoma, United States, 73134

Actively Recruiting

24

Miriam Hospital

Providence, Rhode Island, United States, 02906

Actively Recruiting

25

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

26

Tennessee Center for Clinical Trials

Tullahoma, Tennessee, United States, 37388

Suspended

27

El Paso Cardiology

El Paso, Texas, United States, 79912

Actively Recruiting

28

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

29

Texas Cardiac and Vascular Institute San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

30

Christus Health

Tyler, Texas, United States, 75702

Actively Recruiting

31

LKH-Universitätsklinikum Graz

Graz, Austria, A-8036

Actively Recruiting

32

Ambroise Paré Hospital

Boulogne-Billancourt, France, 92100

Actively Recruiting

33

Hôpital St. Joseph

Paris, France, 75014

Actively Recruiting

34

Alexianer Klinikum Hochsauerland

Arnsberg, Germany, 59759

Actively Recruiting

35

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, Germany, 79189

Actively Recruiting

36

Krankenhaus Buchholz

Buchholz, Germany, 21244

Actively Recruiting

37

Sana Kliniken Oberfranken Coburg

Coburg, Germany, 96450

Actively Recruiting

38

University of Essen

Essen, Germany, 45147

Actively Recruiting

39

Universitatsklinikum Tubingen

Tübingen, Germany

Actively Recruiting

40

Queen Mary Hospital

Hong Kong, Pok Fu Lam, Hong Kong

Actively Recruiting

41

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

Actively Recruiting

42

Ospedale Pederzoli

Peschiera del Garda, Verona, Italy, 37019

Actively Recruiting

43

UGC - Maria Cecilia Hospital

Cotignola, Italy, 48033

Actively Recruiting

44

Ospedale Policlinico San Martino

Genova, Italy, 16132

Terminated

45

St. Antonius Hospital

Nieuwegein, Netherlands, 3435 CM

Actively Recruiting

46

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

47

Singapore General Hospital

Singapore, Singapore, 169856

Actively Recruiting

48

Inselspital Bern

Bern, Switzerland

Terminated

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Research Team

K

Kara Piscani

CONTACT

T

Tamarah Suys

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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