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Percutaneous Deep Vein Arterialization for Treatment of Late-Stage Critical Limb Ischemia, Early Feasibility Results


Jihad Mustapha, MD, FACC, FSCAI, Advanced Cardiac and Vascular Amputation Prevention Center, Grand Rapids, Michigan

Abstract Number
AMP 2018-7

Purpose: Within critical limb ischemia (CLI) there is a broad spectrum of severity, from milder degrees of vascular insufficiency to no-option situations where occlusive lesions are so complex that current available surgical and endovascular techniques are not sufficient and amputation is considered the only solution. We report the interim results of the multicenter PROMISE Early Feasibility Trial using the LimFlow Stent Graft System (LimFlow, Inc.; Santa Clara, California) for percutaneous deep vein arterialization (pDVA) in these no-option patients. Materials and Methods: Ten no-option CLI patients (median age, 67 years; 3 women) were enrolled to determine the safety, effectiveness, and feasibility of the LimFlow Stent Graft System. All patients were Rutherford Category 5 or 6. Eight were classified at high risk of amputation based on the SVS WIfI classification. The primary safety endpoint was Amputation Free Survival (AFS, freedom from mortality and freedom from above-ankle amputation of the index limb) at 30 days with a secondary safety endpoint of AFS at 6 months. Other secondary endpoints included patency, wound healing, and technical success. Results: The primary safety endpoint was achieved in 100% of patients, with no deaths or above-the-ankle amputations at 30 days. The technical success rate was 100%. Conclusions: pDVA using the LimFlow Stent Graft System is a novel approach for treating patients with no-option CLI and may reduce amputation in this population for whom amputation would otherwise be considered inevitable. Initial findings from this early feasibility trial appear promising, and additional study via pivotal trial is warranted.

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