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

NCT07014475 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-06-11

No results posted yet for this study

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

DEVICE

drug-coated balloon

Drug-coated balloon was used during the index procedure.

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2028-06-30
Completion
2029-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014475 on ClinicalTrials.gov