Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
120 participants
INTERVENTIONAL
2024-04-16
2030-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treated with 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Aveera Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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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
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
Weill Cornell Medical Center
New York, New York, United States
Sunrise Vascular
Murphy, North Carolina, United States
Advanced Vascular Centers
Tigard, Oregon, United States
Penn Medicine
Philadelphia, Pennsylvania, United States
UT Southwestern Medical Center
Dallas, Texas, United States
HOPE Vascular and Podiatry
Houston, Texas, United States
University of Washington Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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Protocol # 24-01
Identifier Type: -
Identifier Source: org_study_id
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