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Chronic Limb-Threatening IschemiaNCT06311773

Pivotal Trial of the Boomerang Catheter for pDVA

A study testing Boomerang Catheter in people with Chronic Limb-Threatening Ischemia, run by Aveera Medical, Inc. at 25 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Limb-Threatening Ischemia
What is being tested?
Boomerang Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
25 sitesUnited States
Study dates
16 Apr 2024to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is age ≥ 18 years
  • 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.
  • 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.
  • Inflow artery criteria:
  • Imaging confirmation of patent inflow artery (< 50% stenosis) from Aortic bifurcation to tibial trifurcation.
  • Target conduit vein criteria:
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  • 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.
  • Patient may be scheduled for a planned minor amputation (toe, ray, or trans-metatarsal) within 30 days after index procedure.
  • Prior stent(s) to inflow arteries (i.e., Iliac, SFA, Popliteal) are allowed.
  • Patient is willing and able to provide written informed consent.
  • Patient meets institutional criteria for procedure clearance and is able to comply with study requirements per PI judgement.
  • Diabetic patients have adequate glycemic control per investigator judgement.
  • Female patients of childbearing potential have a negative pregnancy test within 7 days prior to index procedure (urine)
  • 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.
  • PI determines that the primary wound is stable (e.g., not rapidly deteriorating or showing signs of healing).

Who cannot join

  • Life expectancy < 12 months.
  • 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).
  • Patient is dialysis dependent.
  • Significant acute or chronic kidney disease with a serum creatinine of > 2.5 mg/dl in patients not undergoing dialysis.
  • Prior peripheral arterial bypass procedure on index limb within 30 days.
  • Previous major amputation of the target limb or absence of adequate viable tissue for below-ankle (e.g., mid-foot) amputation.
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  • Patient is non-ambulatory due to above-ankle amputation of contralateral limb.
  • 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.
  • 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.
  • 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.
  • Patient has had a stroke within the previous 3 months with residual Rankin score of ≥ 2.
  • NYHA Class IV heart failure which may compromise patient's ability to safely undergo a percutaneous procedure, per PI judgment.

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

25 sites in 1 country

United States25 sites

  • St. Luke's University Hospital

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • VIC Vascular Institute

    Chattanooga, Tennessee, 37421

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Vascular Institute at AMI

    Galloway, New Jersey, 08205

  • Cardiovascular Institute of the South

    Houma, Louisiana, 70360

  • Baylor College of Medicine

    Houston, Texas, 77030

  • HOPE Vascular and Podiatry

    Houston, Texas, 77054

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32256

  • Northwell Health - Lake Success

    Lake Success, New York, 11042

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Sunrise Vascular

    Murphy, North Carolina, 28906

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Penn Medicine

    Philadelphia, Pennsylvania, 19104

  • Arrowhead Regional Medical Center

    San Bernardino, California, 92324

  • University of Washington Medicine

    Seattle, Washington, 98133

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Olive View-UCLA Medical Center

    Sylmar, California, 91342

  • Advanced Vascular Centers

    Tigard, Oregon, 97223

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

    Torrance, California, 90502

  • American Endovascular and Amputation Prevention

    West Orange, New Jersey, 07052

  • PIH Whittier Hospital

    Whittier, California, 90602

  • EndoVascular Consultants

    Wilmington, Delaware, 19805

Other trials in United States

About this study

Official title: Pivotal Multicenter Trial of the Boomerang® Catheter for Percutaneous Deep Vein Arterialization (pDVA)

The purpose of this study is to establish the safety and effectiveness of the Boomerang Catheter for percutaneous Deep Venous Arterialization (pDVA) to treat no-option Chronic Limb-Threatening Ischemia.

Being tested
Boomerang Catheter
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Boomerang CatheterDevice

    The study device used for this procedure makes an anastomosis between a tibial vein and a tibial artery to direct blood flow around blocked arteries.

Study groups in NCT06311773
Study groupRoleWhat they receive
Treated with Boomerang CatheterExperimentalNot described
Receives: Device: Boomerang Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amputation Free Survival (AFS)

    Freedom from above-ankle amputation of the index limb or death (any cause) at 6 months, compared to a literature derived performance goal.

    Measured: 6-months

Secondary outcomes (8)

  1. Technical success

    Successful deployment of the Boomerang Catheter to the anastomosis site, creation of an anastomosis, and confirmation of fistula flow using angiography or Doppler ultrasound immediately post catheter activation.

    Measured: During index procedure

  2. Procedural success

    confirmation of retrograde fistula flow in the target tibial vein conduit at index procedure completion.

    Measured: Immediately post index procedure

  3. Limb salvage

    Freedom from above-ankle amputation of the index limb.

    Measured: 3 years post index procedure

  4. Primary patency

    Time from fistula creation to the first intervention to maintain or reestablish flow through the fistula or to fistula occlusion.

    Measured: 1 year post index procedure

  5. Primary assisted patency

    Time from fistula creation to the first occlusion of the fistula.

    Measured: 1 year post index procedure

  6. Secondary patency

    Time from fistula creation to abandonment (e.g., decision to decline intervention due to occlusion) of the fistula.

    Measured: 1 year post index procedure

  7. Target wound healing

    Complete or in-process healing of the patient's target wound(s).

    Measured: 1, 3, 6, 9-months, and 1-year

  8. Complete wound healing

    Complete healing of all the patient's ischemic wound(s) in the index limb.

    Measured: 1, 3, 6, 9-months, and 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start16 Apr 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06311773
Sponsor's protocol ID
Protocol # 24-01
Status last verified
Jul 2026
First submitted
8 Mar 2024
Last updated
24 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Boomerang Catheter in people with Chronic Limb-Threatening Ischemia, run by Aveera Medical, Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amputation Free Survival (AFS) (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06311773.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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