Safety and Effectiveness of the Santreva™-ATK Endovascular Revascularization Catheter in the RESTOR-1 Peripheral CTO Crossing Pivotal Study

Data on recanalization of femoropopliteal (FP) chronic total occlusions (CTOs) and characterization of the traversed crossing track are limited. The AngioSafe Peripheral-2 CTO Crossing Catheter (Santreva™-ATK) was evaluated in a prospective, single-arm, multicenter trial conducted at 14 U.S. sites. Adults ≥18 years with Rutherford class (RC) 2–5 peripheral arterial disease and de novo FP CTOs ≤30 cm in length with at least 1 patent distal runoff vessel were eligible. The primary endpoint was clinical success, defined as device-facilitated guidewire placement into the distal true lumen without device-related major adverse events (MAEs) within 24 hours or through discharge, benchmarked to a 70% performance goal. Angiography and/or intravascular ultrasound (IVUS) were performed before definitive therapy. Seventy-four subjects (mean age 69.4 ± 9.0 years; 35% women; 45% with diabetes mellitus; 82% current or former smokers) were enrolled, with antegrade crossing used in all cases. The mean target CTO length was 131.6 ± 90.4 mm. The primary endpoint was achieved in 87.8% (95% Confidence Interval or CI 0.78–0.94) patients overall; 90% per protocol (95% CI 0.80-0.96); in moderate-to-severe calcification (n=53), 86.7% (95% CI 0.74–0.94) overall and 88% (95% CI 0.76-0.95) per protocol. IVUS (n = 54) demonstrated 80% exclusively intraplaque crossings. The device created an angiographically visible channel (mean diameter 2.87 ± 0.74 mm; reference vessel diameter 4.9 ± 0.89 mm), corresponding to a 59% luminal gain. At 30 days, mean RC improved from 3.40 ± 0.09 to 1.25 ± 0.20 and pain score from 5.24 ± 0.36 to 2.06 ± 0.33 (both p < 0.001). No device-related MAEs occurred through 30 days. Santreva TM -ATK demonstrated high rates of procedural success, intraplaque passage, and safety in FP CTOs, including heavily calcified lesions, with no device-related MAEs.