Clinical Outcomes of Santreva-ATK Endovascular Revascularization Catheter in Patients With Claudication and Critical Limb-Threatening Ischemia.

Patients with femoropopliteal (FP) chronic total occlusions (CTOs) presenting with intermittent claudication (IC) and chronic limb threatening ischemia (CLTI) differ in disease severity and lesion complexity. We performed a subgroup analysis of the prospective, multicenter RESTOR-1 trial to evaluate the safety and effectiveness of the Santrev-ATK Endovascular Revascularization Catheter in these patient populations. Compare procedural and short-term clinical course outcomes of the Santreva-ATK catheter in patients with IC and CLTI enrolled in RESTOR-1 pivotal trial. About 74 patients with Rutherford class (RC) 2 to 5 peripheral artery disease and de novo FP CTOs were stratified into IC (RC 2 to 3, n = 48) and CLTI (RC 4 to 5, n = 26). The primary endpoint was clinical success, defined as successful device-facilitated guidewire placement into the distal true lumen without device-related major adverse events (MAEs). Secondary endpoints included procedural success, intravascular (IVUS)-determined crossing trajectory, and 30-day clinical outcomes. Clinical success was achieved in 89.6% of patients with IC and 84.6% of patients with CLTI, with similarly high technical and procedural success rates between groups. IVUS evaluation was performed in 85.4% (41/48) of patients with IC and 76.9% (20/26) of patients with CLTI. Among patients with documented crossing trajectory, 86.9% (53/61) demonstrated intraplaque crossing and 13.1% (8/61) demonstrated extraplaque crossing. Although patients with CLTI had a numerically higher prevalence of diabetes mellitus and heavily calcified lesions, these differences were not statistically significant, and crossing performance remained comparable between groups. Santreva-ATK catheter demonstrated high clinical success and an excellent safety profile across the spectrum of FP CTO disease, supporting its use in both IC and CLTI patients.