Pivotal Trial of the Boomerang Catheter for pDVA

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Limb-Threatening Ischemia
• Intervention / Treatment: Device: Boomerang Catheter

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Whittier, California, United States, 90602
      • PIH Whittier Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19805
      • EndoVascular Consultants
  • Florida
    • Jacksonville, Florida, United States, 32256
      • First Coast Cardiovascular Institute
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • New Jersey
    • Galloway, New Jersey, United States, 08205
      • Vascular Institute at AMI
    • West Orange, New Jersey, United States, 07052
      • American Endovascular and Amputation Prevention
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
  • North Carolina
    • Murphy, North Carolina, United States, 28906
      • Sunrise Vascular
  • Oregon
    • Tigard, Oregon, United States, 97223
      • Advanced Vascular Centers
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Medicine
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • VIC Vascular Institute
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern Medical Center
    • Houston, Texas, United States, 77054
      • HOPE Vascular and Podiatry
  • Washington
    • Seattle, Washington, United States, 98133
      • University of Washington Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated with Boomerang Catheter	Device: Boomerang Catheter; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During index procedure
Procedural success	confirmation of retrograde fistula flow in the target tibial vein conduit at index procedure completion.	Immediately post index procedure
Limb salvage	Freedom from above-ankle amputation of the index limb.	3 years post index procedure
Primary patency	Time from fistula creation to the first intervention to maintain or reestablish flow through the fistula or to fistula occlusion.	1 year post index procedure
Primary assisted patency	Time from fistula creation to the first occlusion of the fistula.	1 year post index procedure
Secondary patency	Time from fistula creation to abandonment (e.g., decision to decline intervention due to occlusion) of the fistula.	1 year post index procedure
Target wound healing	Complete or in-process healing of the patient's target wound(s).	1, 3, 6, 9-months, and 1-year
Complete wound healing	Complete healing of all the patient's ischemic wound(s) in the index limb.	1, 3, 6, 9-months, and 1-year

Collaborators and Investigators

• Sponsor: Aveera Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Ischemia; Peripheral Arterial Disease; Pathological Conditions, Signs and Symptoms; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: Protocol # 24-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No