What is SELUTION SLR14 DEB studying for peripheral arterial disease?

SELUTION SLR14 DEB is being studied to see how well it works and how safe it is compared to a plain balloon to open narrowed arteries below the knee in people with chronic limb-threatening ischemia. The study aims to find better treatment options for this serious condition. The trial is sponsored by M.A. Med Alliance S.A.

Who may be eligible for this peripheral arterial disease clinical trial?

Adults aged 18 years or older with chronic limb-threatening ischemia affecting below-the-knee arteries may be eligible. Participants need to have specific artery narrowings suitable for balloon treatment and be able to provide consent. People with severe kidney problems, recent major amputations, or certain infections may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this peripheral arterial disease clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel expenses or other costs are not guaranteed to be covered and may vary. Participants should plan accordingly for any out-of-pocket expenses.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05055297

SELUTION SLR14 014 BTK A Randomized Study Assessing Safety and Effectiveness of SELUTION SLR14 Drug Eluting Balloon for Below-the-Knee Atherosclerotic Disease in Chronic Limb Threatening Ischemia

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

376

Participants Needed

Research Sites

269 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the SELUTION SLR14 Drug Eluting Balloon DEB compared to plain uncoated balloon angioplasty in patients with peripheral arterial disease PAD affecting the below-the-knee BTK arteries, specifically in those with chronic limb-threatening ischemia CLTI. The study aims to show that the SELUTION SLR14 DEB has better efficacy and similar safety compared to the uncoated balloon treatment. Participants are adults aged 18 years or older with documented CLTI and significant narrowing in BTK arteries. The trial randomly assigns participants to one of two groups one receiving the SELUTION SLR14 DEB and the other receiving plain balloon angioplasty. Both are non-surgical procedures where a catheter inflates a balloon to open narrowed arteries below the knee. Treatments target specific lesions in BTK arteries and must meet detailed angiographic criteria. The study uses a single-blind design and includes follow-up assessments over several years. Participants will undergo evaluations at multiple time points including 30 days, 6 months, and up to 36 months after treatment. Assessments include clinical improvement, amputation rates, wound healing, imaging, and quality of life measures. Safety endpoints are monitored early, while efficacy outcomes are tracked long term. The study also evaluates device and procedural success immediately after treatment. Overall participation may last over three years to gather comprehensive safety and effectiveness data.

CONDITIONS

Brief Title

SELUTION4BTK Trial

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

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 for more than 2 weeks
Willing and able to provide written informed consent and comply with follow-up
Female participants of childbearing potential must be non-breastfeeding and have a negative pregnancy test within 7 days before procedure
Target lesions must be de novo or non-stented restenotic in BTK arteries distal to tibial plateau and above tibiotalar joint
Target lesions with diameter stenosis of 70% or more, suitable for balloon angioplasty
Target vessel diameter between 2 mm and 4 mm
Target lesions confined to a single vessel with total lesion length between 30 mm and 140 mm
Patent tibial and pedal runoff distal to target lesions or normal terminal branching as specified
Free of significant inflow vessel disease or successfully treated inflow disease
Successful lesion preparation with residual stenosis less than or equal to 30% and no flow-limiting dissection before randomization

You will not qualify if you...

Extensive tissue loss (Rutherford category 6) requiring complex reconstruction or large flap coverage
Chronic renal insufficiency requiring dialysis or GFR ≤ 30 ml/min/1.73 m2
Acute renal insufficiency within 48 hours before procedure
Acute limb ischemia with symptoms less than 2 weeks
Neuropathic, venous, or mixed wounds
Prior major amputation of the ipsilateral leg or planned major amputation
Iliac or common femoral artery bypass within 6 weeks
Recent or planned surgical or endovascular procedures within 14 to 30 days (with some exceptions)
Prior drug-coated balloon or stent treatment of target lesion within 1 year or any prior stent with significant restenosis
Need for treatments such as thrombolysis, stenting, brachytherapy, or re-entry devices
Target lesion requires pedal or upper extremity access
Recent treatment with limus-based drug devices within 3 months
Allergy to Sirolimus or other required agents
Contraindication to antiplatelet therapy
Recent disabling stroke or STEMI within 3 months
Acute coronary syndrome (except stabilized)
Non-atherosclerotic disease of target vessel or Buerger's disease
Hypercoagulable or coagulopathy conditions
Systemic infection with leukocytosis or fever
Immune compromised conditions or immune-suppressive treatments
Current or planned cancer treatment or metastatic disease
NYHA class IV heart failure
Bedridden status
Body mass index less than 18
Participation in another investigational study without completed follow-up
Other conditions limiting participation or compliance
Presence of stent in target vessel unless lesion is sufficiently distant and mild restenosis
Significant inflow disease in common femoral or profunda femoris arteries
Unsuccessful lesion pre-dilatation or intra-arterial thrombus or embolism
Need for treatment below tibiotalar joint or pedal arteries

Research Team

Kara Piscani

Tamarah Suys

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