Boomerang Stentless Deep Vein Arterialization for Preventing Major Amputation in Peripheral Arterial DIsease/CLTI

Study evaluating efficacy of using a novel stentless device for Deep Vein Arterialization (TADV) procedures for patients with Chronic Limb Threatening Ischemia (CLTI) which is seen in late stages of Peripheral Arterial Disease (PAD) that would usually face a Major Amputation, considered as "no option". The Interventional Radiology team has already successfully been performing DVA for many years and were part of previous trials for Stent based DVA systems. This system has the potential to create a DVA without the need for permanent stents, which may reduce some of the complications seen with stent based systems, and could possibly reduce overall cost. Dr. Madassery has already enrolled a patient and successfully performed the procedure, already in followup.

In order to participate you must meet the following 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.
• 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 will be excluded from the study if any of the following criteria apply to you:

• 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.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.