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New drug balloon could keep leg arteries open longer

NCT ID NCT05132361

Disease control Sponsor: M.A. Med Alliance S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a special balloon coated with a drug (SELUTION SLR™ 018) to open narrowed leg arteries in people with peripheral arterial disease. About 300 participants will be randomly assigned to receive either the drug-coated balloon or a standard uncoated balloon. The goal is to see if the drug balloon keeps arteries open longer and reduces the need for repeat treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-coated balloon (SELUTION SLR™ 018)
What this could lead to
If it works, this could offer a better, longer-lasting treatment for blocked leg arteries, reducing the need for repeat procedures.
What could go wrong
This is an early-stage study with 300 participants, so results may not apply to everyone. Risks include artery damage, re-narrowing, or no benefit over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

300 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Clinical Inclusion Criteria: 1. Subject age is ≥ 18 years or minimum legal age as required by local regulations. 2. Life expectancy \>1 year in opinion of investigator. 3. Documented ischemia with Rutherford classification category 2, 3 or 4. 4. Target lesion(s) in the SFA or PPA. 5. Able to walk without the assistance of a walker. 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations. 7. 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: 1. Angiographic evidence that target lesion lies within the superficial femoral artery and/or proximal popliteal artery (P1 and P2 only). 2. 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. 3. Target vessel reference diameter ≥4mm and ≤7mm. 4. 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. 5. 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. PK Sub-Study Inclusion Criteria: Subjects must meet all of the main protocol inclusion criteria to participate in the PK sub-study. Subjects must also meet the following additional PK sub-study inclusion criteria: 1\. Subject is willing and able to provide informed consent for the PK sub-study and comply with the PK sub-study procedures and required follow-up evaluations. Clinical Exclusion Criteria: 1. 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. 2. Inability to tolerate dual antiplatelet therapy. 3. 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. 4. Stroke or MI within 3 months of enrollment. 5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia). 6. 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. 7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb. 8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease) 9. 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). 10. Subject has target lesion(s) that require treatment via pedal site. 11. Subject has target lesion(s) that require access via upper extremity arteries. 12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter. 13. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure). 14. Systemic infection (WBC \> 12,000 and febrile) or known immune compromise. 15. Breast-feeding woman. 16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up. Angiographic Exclusion Criteria: 1. Presence of a previously placed stent in the treated artery. 2. Failure to successfully cross the target lesion. 3. Residual stenosis ≥30% after pre-dilatation. PK Sub-Study Exclusion Criteria: 1. Subjects must meet none of the main protocol exclusion criteria (Section 6.1.2 of the main protocol) to participate in the PK sub-study. Subjects will be excluded if any of the following additional PK sub-study exclusion criteria are met: 2. Any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device has been placed/used in any part of the body within 3 months prior to the index procedure including non-target lesion(s) treated during the index procedure. 3. Planned intervention with any limus family (Zotarolimus, Everolimus, Sirolimus etc.) eluting device anywhere in the body within 6 months after the index procedure. Note: staged procedures \>30 days after index procedure (Exclusion #20 and #22 of the main protocol) are permitted only in the main protocol, and are not permitted in this PK sub-study. 4. The subject is taking or has taken within the last 3 months any limus family medication(s) for any reason. 5. Subjects who are taking strong CYP3A4 Inhibitors within 14 days before the index procedure or plan to take the strong inhibitors during the study period. Strong inhibitors include: cobicistat; ritonavir; indinavir and ritonavir; itraconazole; ketoconazole; lopinavir and ritonavir; paritaprevir and ritonavir and ombitasvir (and/or dasabuvir); posaconazole; saquinavir and ritonavir; tipranavir and ritonavir; elvitegravir and ritonavir; telithromycin; voriconazole; ceritinib; clarithromycin; idealalisib; nefazodone; nelfinavir. 6. Subjects who are taking strong CYP3A4 Inducers within 14 days before the index procedure or plan to take the strong inducers during the study period. Strong inducers include apalutamide; carbamazepine; enzalutamide; ivosidenib; lumacaftor and ivacaftor; mitotane; phenytoin; rifampin; St. John's wort.

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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease Superficial femoral artery stenosis

Contacts and locations

Locations

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Alexianer Klinikum Hochsauerland

    Arnsberg, 59759, Germany

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Cardiovascular Consultants of South Georgia

    Thomasville, Georgia, 31792, United States

  • Cardiovascular Institute of the South

    Gray, Louisiana, 70359, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • ClinRé

    Thornton, Colorado, 80023, United States

  • El Paso Cardiology

    El Paso, Texas, 79902, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32218, United States

  • Guardian Research Organization, LLC

    Winter Park, Florida, 32792, United States

  • Heart Care Centers Research Foundation

    Palos Park, Illinois, 60464, United States

  • Heart Hospital Baylor Plano

    Plano, Texas, 75093, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • James J. Peters VA Medical Center

    The Bronx, New York, 10468, United States

  • Krankenhaus Buchholz

    Buchholz, 21244, Germany

  • Manatee Memorial Hospital

    Bradenton, Florida, 34205, United States

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782, United States

  • Memorial Healthcare System

    Hollywood, Florida, 33021, United States

  • Mercy Hospital

    St Louis, Missouri, 63128, United States

  • Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538, United States

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607, United States

  • Palm Vascular Centers

    Miami Beach, Florida, 33140, United States

  • Queen Mary Hospital

    Hong Kong, Pok Fu Lam, Hong Kong

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022, Germany

  • Sana Kliniken Oberfranken Coburg

    Coburg, 96450, Germany

  • St. Helena Hospital

    St. Helena, California, 94558, United States

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388, United States

  • Texas Cardiac and Vascular Institute San Antonio

    San Antonio, Texas, 78229, United States

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, Florida, 32605, United States

  • The Chinese University of Hong Kong

    Shatin, Hong Kong

  • University Clinic Tübingen

    Tübingen, 72076, Germany

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, 79189, Germany

  • Universitätsklinikum Graz

    Graz, A-8036, Austria

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Vascular Care Group

    Darien, Connecticut, 06820, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.