DEEPER REVEAL: The Bare Temporary Spur Stent System for the Treatment of Critical Limb Ischemia

J. Mustapha

Purpose: To evaluate the safety and efficacy of the Bare Temporary Spur Stent System for the treatment of infrapopliteal disease in subjects with critical limb ischemia (CLI).

Materials and Methods: The DEEPER REVEAL trial is a prospective, nonrandomized, multicenter, single-arm trial with follow-up at 2 weeks for participants with wounds (Rutherford class 5); 1, 3, 6, and 12 months. Up to 130 participants will be enrolled at up to 50 investigational centers inside and outside of the United States. The study will compare the safety and efficacy of the Bare Temporary Spur Stent System in participants with infrapopliteal CLI to a predefined performance goal based on standard percutaneous transluminal balloon angioplasty (PTA). The primary efficacy endpoint is technical success defined as less than 30% residual stenosis, and the co-primary safety endpoint is freedom from the occurrence of major adverse limb events (MALE) and perioperative death, at 30 days after the 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 participants have reached 30 days of 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 participant 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 CLI. The DEEPER REVEAL trial is the first US-based trial to examine the safety and efficacy of this device.