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New stent aims to save legs from amputation

NCT ID NCT05358353

Disease control Sponsor: ReFlow Medical, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a temporary stent designed to open blocked arteries below the knee in people with peripheral artery disease or critical limb ischemia. The goal was to improve blood flow and prevent serious complications like amputation. The trial involved 130 participants and measured how well the stent worked and its safety within 30 days.

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

130 people

The number who actually took part.

Started

Oct 2022

Finished

May 2025

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.

Pre-Procedure Inclusion Criteria: 1. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a witness, including a family member, sign on their behalf. 2. Life expectancy greater than 1 year in the investigator's opinion. 3. Male or non-pregnant female ≥18 years of age at time of consent. 4. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation. 5. For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure. Angiographic Inclusion Criteria: 1. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing). 2. Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior. Note: 1. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions. 2. Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not fractured or otherwise compromised. 3. Distal embolic protection is strongly encouraged in cases where atherectomy is used. 4. Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments. 5. Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting dissection, thrombus, or aneurysm by angiography. 3. Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint. Note: 1. If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot. 2. If the peroneal artery is treated, there must be at least one collateral supplying the foot. 3. In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries 4. Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment. 5. Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site: 1. Intravascular Ultrasound (IVUS) (primary) 2. Visual estimate using Angiography (secondary) 6. Target lesion length is less than or equal to 210mm in length. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm. 7. Successful pre-dilatation of the target lesion defined as resulting in stenosis less than or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm in diameter, without resulting flow limiting dissection, thrombus, or aneurysm by angiography prior to the insertion of the Bare Temporary Spur Stent System. 8. Only one limb and one contiguous vessel may be enrolled per subject. If required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Note: 1. Distal embolic protection is strongly recommended in cases using atherectomy. 2. Treatment of the target vessel/lesion may be performed only if treatment of the non-target lesion is successful without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography. 3. Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion. 9. If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed less than or equal to 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure. 10. Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the Bare Temporary Spur Stent System must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access. Pre-procedure Exclusion Criteria: 1. Subject unwilling or unlikely to comply with the 1-year duration of the study in the opinion of the investigator. 2. Subject is pregnant or planning to become pregnant during the course of the trial. 3. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia. 4. Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted. 5. Wounds must be confined to the foot below the ankle. Heel wounds are excluded. 6. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted. 7. Recent myocardial infarction or stroke less than 90 days prior to the index procedure. 8. Symptomatic acute heart failure NYHA class III or greater. 9. Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis. 10. Inability to tolerate dual antiplatelet and/or anticoagulation therapy. 11. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure. 12. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints. 13. Known allergy to nitinol or nickel. 14. Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted. Angiographic Exclusion Criteria 1. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments. 2. Fractured or otherwise compromised stents in the target vessel or inflow vessel. 3. In-stent restenosis in the target vessel. 4. Previous treatment of inflow lesions performed less than or equal to 7 days prior to the index procedure. 5. Previous treatment of the target vessel less than or equal to 90 days prior to index procedure. 6. Angiographic evidence of thrombus within target limb. 7. Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA. 8. Type D dissections or greater incurred during CTO crossing (see Appendix I for definitions). 9. Significant (greater than or equal to 50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions. 10. Distance from access to lesion is too long for a 135 cm working length of the Bare Temporary Spur Stent System catheter.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia peripheral arterial disease

As listed by the trial registrant

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

Critical limb ischemia Peripheral arterial disease

Contacts and locations

Locations

  • Advanced Cardiac and Vascular Centers for Amputation Prevention

    Grand Rapids, Michigan, 49525, United States

  • Advanced Heart and Vascular Institute of Hunterdon

    Flemington, New Jersey, 08822, United States

  • Advanced Vascular Surgery

    Kalamazoo, Michigan, 49048, United States

  • Ansaarie Cardiac & Endovascular Center of Excellence

    Palatka, Florida, 32177, United States

  • Arkansas Heart Hospital

    Little Rock, Arkansas, 72211, United States

  • Baptist Hospital of Miami

    Miami, Florida, 33176, United States

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70809, United States

  • Bradenton Cardiology

    Bradenton, Florida, 34205, United States

  • Cardiovascular Institute of the South

    Lafayette, Louisiana, 70506, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Coastal Vascular and Interventional Center

    Pensacola, Florida, 32503, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Community Healthcare Systems

    Munster, Indiana, 46321, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Eastlake Cardiovascular PC

    Roseville, Michigan, 48066, United States

  • El Paso Cardiology Associates

    El Paso, Texas, 79902, United States

  • First Coast Cardiovascular Institute

    Fleming Island, Florida, 32003, United States

  • Guardian Research

    Winter Park, Florida, 32792, United States

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666, United States

  • Lankenau Institute for Medical Research

    Bryn Mawr, Pennsylvania, 19010, United States

  • Massachusetts General Hospital

    Somerville, Massachusetts, 02114, United States

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425, United States

  • Mercy South

    St Louis, Missouri, 63128, United States

  • Midwest Cardiovascular Institute

    Naperville, Illinois, 60540, United States

  • Novant Health Heart & Vascular Institute

    Matthews, North Carolina, 37232, United States

  • Ochsner Health

    New Orleans, Louisiana, 70121, United States

  • Ohio Health

    Columbus, Ohio, 43214, United States

  • Palm Beach Heart and Vascular

    Boynton Beach, Florida, 33436, United States

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045, United States

  • Rush University

    Chicago, Illinois, 60612, United States

  • Sentara Norfolk General

    Norfolk, Virginia, 23507, United States

  • Southern CT Vascular Center

    Shelton, Connecticut, 06484, United States

  • St. Bernards Heart and Vascular

    Jonesboro, Arkansas, 72401, United States

  • Sunrise Vascular

    Murphy, North Carolina, 28906, United States

  • Surgical Specialists of Ocala

    Ocala, Florida, 34471, United States

  • Texas Cardiac and Vascular Institute

    Corpus Christi, Texas, 78404, United States

  • Texas Tech University Health Sciences Center

    Odessa, Texas, 79430, United States

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • UnityPoint Health Trinity Bettendorf Hospital

    Bettendorf, Iowa, 52722, United States

  • University of California, Irvine Health

    Orange, California, 92868, United States

  • University of Missouri

    Columbia, Missouri, 65211, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vascular & Interventional Specialist of Orange County

    Orange, California, 92868, United States

  • Vascular Care Connecticut (site) / Vascular Breakthroughs (research support)

    Darien, Connecticut, 06820, United States

  • Vascular Care Group (site) / Vascular Breakthroughs (research support)

    Wellesley, Massachusetts, 02482, United States

More trials for these conditions

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