Pivotal Multicenter Trial of the Boomerang® Catheter for Percutaneous Deep Vein Arterialization (pDVA)

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 (\…