Pivotal Trial of the Boomerang Catheter for pDVA

NCT06311773 | Enrolling By Invitation FDA Device

• 1 other identifier: Protocol # 24-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Chronic Limb-Threatening Ischemia

Outcome Measures

Primary Outcomes (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.

  6-months

Secondary Outcomes (8)

• Technical success

  During index procedure

• Procedural success

  Immediately post index procedure

• Limb salvage

  3 years post index procedure

• Primary patency

  1 year post index procedure

• Primary assisted patency

  1 year post index procedure

Study Arms (1)

Treated with Boomerang Catheter

EXPERIMENTAL

Device: Boomerang Catheter

Interventions

Boomerang Catheter DEVICE

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.

Treated with Boomerang Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aveera Medical, Inc.: lead

Study Sites (19)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

PIH Whittier Hospital

Whittier, California, 90602, United States

Location

EndoVascular Consultants

Wilmington, Delaware, 19805, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Vascular Institute at AMI

Galloway, New Jersey, 08205, United States

Location

American Endovascular and Amputation Prevention

West Orange, New Jersey, 07052, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Sunrise Vascular

Murphy, North Carolina, 28906, United States

Location

Advanced Vascular Centers

Tigard, Oregon, 97223, United States

Location

Penn Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

VIC Vascular Institute

Chattanooga, Tennessee, 37421, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

HOPE Vascular and Podiatry

Houston, Texas, 77054, United States

Location

University of Washington Medicine

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 16, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)