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

NCT07014475 NOT_YET_RECRUITING

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).

Details

Lead sponsorFirst Affiliated Hospital, Sun Yat-Sen University
StatusNOT_YET_RECRUITING
Enrolment700
Start dateMon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionMon Jan 01 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

China