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New catheter aims to save limbs when all else fails

NCT ID NCT06311773

Disease control Sponsor: Aveera 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Updated 1 time

Summary

This study tests a device called the Boomerang Catheter in 120 people with chronic limb-threatening ischemia (CLTI), a severe condition where blocked leg arteries can lead to amputation. The catheter creates a connection between a vein and an artery to reroute blood around the blockage. The main goal is to see if this procedure helps patients avoid amputation or death within 6 months.

What this could mean

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

Active substance
Boomerang Catheter
What this could lead to
If successful, this device could offer a new way to save limbs and improve survival for people with severe leg artery blockages who have no other treatment options.
What could go wrong
This is an early-stage trial with only 120 participants and no comparison group, so results may not apply to everyone. Risks include procedural complications like bleeding or infection.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Mar 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.

Inclusion Criteria: 1. Patient is age ≥ 18 years 2. Patient has confirmed clinical diagnosis of Rutherford Category (RC) 5 or 6 Chronic Limb-Threatening Ischemia (CLTI) with previous angiogram or hemodynamic evidence (e.g., ABI ≤ 0.39, TP / TcPO2 \< 30 mm Hg) demonstrating severely diminished arterial perfusion of the index limb. 3. Assessment by the PI and an Independent Review Committee (IRC) determines that patient has no option for conventional distal bypass, surgical or endovascular therapy for limb salvage. 4. Inflow artery criteria: • Imaging confirmation of patent inflow artery (\< 50% stenosis) from Aortic bifurcation to tibial trifurcation. 5. Target conduit vein criteria: • Duplex ultrasound confirms that vein is free from thrombus, contiguous from the intended anastomosis site through the lateral plantar vein, and ≥ 2.0mm lumen-lumen diameter (with tourniquet applied) throughout. 6. Patient may be scheduled for a planned minor amputation (toe, ray, or trans-metatarsal) within 30 days after index procedure. 7. Prior stent(s) to inflow arteries (i.e., Iliac, SFA, Popliteal) are allowed. 8. Patient is willing and able to provide written informed consent. 9. Patient meets institutional criteria for procedure clearance and is able to comply with study requirements per PI judgement. 10. Diabetic patients have adequate glycemic control per investigator judgement. 11. Female patients of childbearing potential have a negative pregnancy test within 7 days prior to index procedure (urine) 12. Patient is enrolled in a wound care network and has an adequate support network to ensure compliance with medication regimen and follow-up study visits. 13. PI determines that the primary wound is stable (e.g., not rapidly deteriorating or showing signs of healing). Exclusion Criteria: 1. Life expectancy \< 12 months. 2. Patient has a lower extremity vascular disease that may inhibit the procedure and/or jeopardize wound healing (e.g., vasculitis, Buerger's disease, significant edema in the target limb, deep venous thrombus in the target vein, hyperpigmentation, or medial ulceration above the ankle). 3. Patient is dialysis dependent. 4. Significant acute or chronic kidney disease with a serum creatinine of \> 2.5 mg/dl in patients not undergoing dialysis. 5. Prior peripheral arterial bypass procedure on index limb within 30 days. 6. Previous major amputation of the target limb or absence of adequate viable tissue for below-ankle (e.g., mid-foot) amputation. 7. Patient is non-ambulatory due to above-ankle amputation of contralateral limb. 8. The patient is currently participating in another investigational drug or device study that has not completed the primary endpoint and that clinically interferes with the endpoints of this study per PI judgement. 9. Patient has known hypersensitivity or contraindication to materials used during the procedure (cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers) or a known contrast sensitivity that cannot be adequately pre-medicated. 10. Patient cannot be adequately treated with study medications due to known contraindication to aspirin, ADP antagonists such clopidogrel, prasugrel or ticagrelor, or anticoagulants such as heparin or bivalirudin. 11. Patient has had a stroke within the previous 3 months with residual Rankin score of ≥ 2. 12. NYHA Class IV heart failure which may compromise patient's ability to safely undergo a percutaneous procedure, per PI judgment.

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Conditions

The condition(s) this trial relates to.

Chronic Limb-Threatening Ischemia limb ischemia

As listed by the trial registrant

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

Chronic limb-threatening ischemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advanced Vascular Centers

    Tigard, Oregon, 97223, United States

  • American Endovascular and Amputation Prevention

    West Orange, New Jersey, 07052, United States

  • Arrowhead Regional Medical Center

    San Bernardino, California, 92324, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • EndoVascular Consultants

    Wilmington, Delaware, 19805, United States

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256, United States

  • HOPE Vascular and Podiatry

    Houston, Texas, 77054, United States

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Northwell Health - Lake Success

    Lake Success, New York, 11042, United States

  • Olive View-UCLA Medical Center

    Sylmar, California, 91342, United States

  • PIH Whittier Hospital

    Whittier, California, 90602, United States

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303, United States

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015, United States

  • Sunrise Vascular

    Murphy, North Carolina, 28906, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • University of Washington Medicine

    Seattle, Washington, 98133, United States

  • VIC Vascular Institute

    Chattanooga, Tennessee, 37421, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Vascular Institute at AMI

    Galloway, New Jersey, 08205, United States

  • Weill Cornell Medical Center

    New York, New York, 10065, United States

More trials for these conditions

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