Clinical Trial

Efficacy of the Ranger Drug-Coated Balloon in Treating BTK Lesions in Patients With CLTI

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
This is a prospective, multicenter, observational study designed to evaluate the clinical outcomes of the Ranger™ SL paclitaxel-coated balloon, a type of drug-coated balloon (DCB), in the treatment of below-the-knee (BTK) lesions in patients with chronic limb-threatening ischemia (CLTI) in China. All enrolled patients will be followed for six months. Patients diagnosed with CLTI who undergo treatment with the Ranger DCB will be included in the study. The primary outcome is the incidence of major adverse events (MAEs).
Trial Details
NCT Number NCT07014475
Lead Sponsor First Affiliated Hospital, Sun Yat-Sen University
Conditions Chronic Limb Threatening Ischemia
Enrollment 700 participants
Start Date 2025-06-30
Primary Completion 2028-06-30 (estimated)
Study Completion 2029-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-06-11