Korean Multicenter Registry of Ranger™ Paclitaxel Coated Balloon for Femoropopliteal Artery Disease: K-Ranger
Chang-Hwan Yoon1, Sun-Hwa Kim2, Seung-Woon Rha3
1Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea. kunson2@snu.ac.kr.
Insights
The Ranger™ drug-coated balloon (DCB) demonstrated high technical success and 89.3% primary clinical patency at 12 months in Korean patients with femoropopliteal artery disease. This study supports the safety and effectiveness of low-dose paclitaxel DCBs in complex lesions.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Drug-coated balloons (DCBs) are crucial for femoropopliteal artery disease (PAD).
- Limited device-specific data exists for Asian populations.
- The Ranger™ paclitaxel-coated balloon (DCB) has shown promise in trials, but real-world Korean data is scarce.
Purpose of the Study:
- To evaluate the real-world performance of the Ranger™ paclitaxel-coated balloon (DCB) in Korean patients with symptomatic femoropopliteal artery disease (PAD).
- To assess primary clinical patency and secondary endpoints at 12 months post-intervention.
Main Methods:
- A prospective, multicenter observational registry.
- 200 consecutive patients with femoropopliteal artery disease treated with Ranger™ DCB.
- Primary endpoint: primary clinical patency; Secondary endpoints: technical success, TLR, mortality, amputation, clinical improvement.
Main Results:
- High technical success rate (99.5%).
- 12-month primary clinical patency was 89.3%.
- Clinically driven target lesion revascularization (TLR) was 3.0%; sustained clinical improvement was 82.3%.
- Risk factors for patency loss included chronic total occlusion, poor runoff, and diabetes.
Conclusions:
- The Ranger™ DCB demonstrated high technical success and favorable 12-month outcomes in a Korean cohort.
- The device proved safe and effective, even in patients with long and complex femoropopliteal lesions.
- Findings support the use of low-dose paclitaxel DCBs and a leave-nothing-behind strategy.
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.
