Clinical Outcomes of Santreva™-ATK Endovascular Revascularization Catheter in Patients with Claudication and Critical Limb-Threatening Ischemia.
Abstract
Background
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 Santreva™-ATK Endovascular Revascularization Catheter in these patient populations.
Objectives
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.
Methods
74 patients with Rutherford class (RC) 2-5 peripheral artery disease and de novo FP CTOs were stratified into IC (RC 2-3, n=48) and CLTI (RC 4-5, 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.
Results
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.
Conclusion
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.