Pivotal Trial of the Boomerang Catheter for pDVA

Enrolling by invitation · Not applicable

Conditions studied: Chronic Limb-Threatening Ischemia

In brief

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.

Key facts

Study ID

NCT06311773

Run by

Aveera Medical, Inc.

People needed

120

Starts

2024-04-16

Expected to finish

2030-03-31

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Arrowhead Regional Medical Center — San Bernardino, California, United States
• Olive View-UCLA Medical Center — Sylmar, California, United States
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• PIH Whittier Hospital — Whittier, California, United States
• EndoVascular Consultants — Wilmington, Delaware, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Vascular Institute at AMI — Galloway, New Jersey, United States
• American Endovascular and Amputation Prevention — West Orange, New Jersey, United States
• Northwell Health - Lake Success — Lake Success, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• Sunrise Vascular — Murphy, North Carolina, United States
• Advanced Vascular Centers — Tigard, Oregon, United States
• St. Luke's University Hospital — Bethlehem, Pennsylvania, United States
• Penn Medicine — Philadelphia, Pennsylvania, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• VIC Vascular Institute — Chattanooga, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• HOPE Vascular and Podiatry — Houston, Texas, United States
• University of Washington Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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