Korean Multicenter Registry of Ranger™ Paclitaxel Coated Balloon for Femoropopliteal Artery Disease: K-Ranger Registry.

BACKGROUND AND OBJECTIVES: Drug-coated balloons (DCBs) are widely used for femoropopliteal artery disease (PAD), yet device-specific data in Asian cohorts remain limited. The Ranger™ paclitaxel-coated balloon uses a low-dose formulation with the TransPax™ excipient, demonstrating favorable results in randomized trials. However, real-world Korean experience has not been systematically evaluated. METHODS: We conducted a prospective, multicenter observational registry of consecutive patients with symptomatic femoropopliteal artery disease treated with the Ranger DCB at 8 Korean centers. The primary endpoint was primary clinical patency. Secondary endpoints included technical success, clinically driven target lesion revascularization (TLR), all-cause death, major or minor amputation, and sustained clinical improvement. RESULTS: Among 200 enrolled patients, 159 completed 12-month follow-up. Mean lesion length was 145.6±79.8 mm, and chronic total occlusions accounted for 43%. Technical success was 99.5%. At 12 months, the estimated primary clinical patency was 89.3%, TLR was 3.0% and sustained clinical improvement was 82.3%. The estimated all-cause death was 8.5%. Only minor amputation occurred in 2.7%. The predicted risk factors for the loss of primary clinical patency were chronic total occlusion, absence of distal runoff vessels, and diabetes mellitus. CONCLUSIONS: In this Korean multicenter registry, the Ranger DCB achieved high technical success and consistent 12-month outcomes despite the long and complex lesion characteristics. These findings support the safety and effectiveness of low-dose paclitaxel DCBs and a leave-nothing-behind strategy in contemporary femoropopliteal interventions.