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

Launched by FIRST AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jun 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special treatment called the Ranger™ drug-coated balloon (DCB) for patients suffering from chronic limb-threatening ischemia (CLTI), a serious condition that reduces blood flow to the legs and can lead to severe complications like gangrene. The trial will take place in multiple centers across China and will follow patients for six months after they receive the treatment. The main goal is to see how many patients experience major health problems related to their condition after using this new balloon treatment.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with CLTI, specifically with symptoms that indicate severe issues in their legs (known as Rutherford categories 4-6). They should also have certain types of blockages in their leg arteries but not have other serious health conditions that could complicate the treatment. Participants will need to agree to join the study and sign a consent form. If eligible, they can expect to receive the Ranger DCB treatment and be monitored for any changes in their health over the six months following the procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years, gender is not limited
• • 2. The patient agreed to participate in the CEIBA study and signed the written informed consent
• • 3. Diagnosis of chronic limb-threatening ischemia (Rutherford category 4-6)
• 4. Gangrene involving any part of the lower extremities or feet, with exclusion of patients who have:
• • 4.1 Pure venous ulcers 4.2 Pure traumatic wounds 4.3 Acute limb ischemia (symptoms present for 2 weeks or less) 4.4 Embolic disease 4.5 Non-atherosclerotic chronic lower extremity vascular diseases (e.g., vasculitis, Buerger's disease, radiation arteritis)
• • 5. Outflow Tract Requirement: At least one direct or indirect, unobstructed outflow vessel in the submalleolar segment of the target limb planned for revascularization.
• 6. Lesion Type:
• • 6.1 Unobstructed blood flow in the suprapopliteal access pathway (including inflow vessels that have been recanalized via staged or concurrent endovascular intervention or hybrid surgery).
• • 6.2 Sub-knee stenotic lesions ≥ 5 cm in length with ≥ 70% diameter reduction. 6.3 Sub-knee occlusive lesions ≥ 1 cm in length. 6.4 Two separate lesions with a minimum 3 cm interval between them may be considered as a single lesion for study inclusion purposes.
• Exclusion Criteria:
• • 1. Presence of life-threatening diseases or comorbidities with an expected life expectancy of less than 1 year.
• • 2. Concurrent participation in another interventional clinical trial requiring informed consent.
• • 3. Diagnosis of Alzheimer's disease.
• • 4. Hematologic disorders or known bleeding tendency.
• • 5. Contraindications to antiplatelet or anticoagulant therapy.
• • 6. Known allergy to contrast agents that cannot be managed with standard premedication (e.g., steroids).
• • 7. Deficiency or dysfunction of protein C, protein S, or antithrombin III (ATIII).
• • 8. New York Heart Association (NYHA) Class III or IV heart failure.
• • 9. Pregnancy or lactation.
• • 10. Prior suprapatellar or infrapatellar amputation of the target limb.
• • 11. Presence of aneurysm, perforation, dissection, or other target vessel injury requiring intervention.
• • 12. Presence of other comorbid conditions (unrelated to the index disease) that affect walking function.
• • 13. History of cardiovascular events within the past 3 months, including nonfatal myocardial infarction, unstable angina, stable angina, nonfatal ischemic stroke, or hemorrhagic stroke.
• • 14. Clinically significant liver or renal dysfunction, as determined by the investigator.
• • 15. Any other condition that, in the opinion of the investigator, would interfere with study treatment or functional assessments.