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Clinical Trials in the USA / NCT06311773
Enrolling by invitation Not applicable

Pivotal Trial of the Boomerang Catheter for pDVA

NCT06311773 · tracked via the Priya Life Science USA tracker
Sponsor
Aveera Medical, Inc.
Phase
Not applicable
Started
2024-04-16
Last updated
2026-07-24

Condition(s) studied

Chronic Limb-Threatening Ischemia

Investigational drug(s) / intervention(s)

Boomerang Catheter

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06311773 on ClinicalTrials.gov ↗ ← All trials in the USA