NCT07014475

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

Efficacy of the Ranger Drug-Coated Balloon in Treating Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 700 (estimated)
• Sponsor: First Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Limb Threatening Ischemia

Interventions

Type	Name	Description
DEVICE	drug-coated balloon	Drug-coated balloon was used during the index procedure.

Timeline

• Start date: 2025-06-30
• Primary completion: 2028-06-30
• Completion: 2029-01-01
• First posted: 2025-06-11
• Last updated: 2025-06-11

Locations

1 site across 1 country: China