090 - DEEPER REVEAL: the Bare Temporary Spur Stent System for the Treatment of Critical Limb Ischemia
Purpose: To evaluate the safety and efficacy of the BareTemporary Spur Stent System for the treatment of infrapopliteal disease in subjects with Critical Limb Ischemia (CLI)
Material and Methods: The DEEPER REVEAL trial is a prospective, non-randomized, multicenter, single arm trial with follow up at 2 weeks for subjects with wounds (Rutherford class 5); 1, 3, 6, and 12 months. Up to 130 subjects will be enrolled at up to 50 investigational centers inside and outside of the US. The study will compare the safety and efficacy of the Bare Temporary Spur Stent System in subjects with infrapopliteal CLI to a pre-defined performance goal based on standard percutaneous transluminal balloon angioplasty (PTA). The primary efficacy endpoint is technical success defined as < 30% residual stenosis, and the co-primary safety endpoint is freedom from the occurrence of major adverse limb events (MALE) and peri-operative death (POD), at 30 days post procedure. A powered secondary efficacy endpoint evaluating limb salvage and primary patency through 6 months will be analyzed provided the co-primary safety and efficacy endpoints are met. An interim analysis for futility is planned when 50% of subjects have reached 30 days follow up. Secondary endpoints include evaluation of acute device and procedure related endpoints, limb salvage, clinical improvement measures, and quality of life measures.
Results: The first subject enrollment will occur in October, 2022. A case study will be presented at the ISET conference, if selected.
Conclusions: The Bare Temporary Spur Stent System is a novel device for the treatment of infrapopliteal disease in patients with critical limb ischemia. The DEEPER REVEAL trial is the first US-based trial to examine the safety and efficacy of this device.