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

Le résumé fourni par la source

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.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.