Pivotal Trial of the Boomerang Catheter for PDVA

Aveera Medical

Status

Invitation-only

Conditions

Chronic Limb-Threatening Ischemia

Treatments

Device: Boomerang Catheter

Study type

Interventional

Funder types

Industry

Identifiers

NCT06311773

Protocol # 24-01

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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).

Exclusion criteria

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.
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 or that clinically interferes with the endpoints of this study.
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.