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

Inclusion criteria

• Age ≥ 18 years, gender is not limited
• The patient agreed to participate in the CEIBA study and signed the written informed consent
• Diagnosis of chronic limb-threatening ischemia (Rutherford category 4-6)
• 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)

• Outflow Tract Requirement: At least one direct or indirect, unobstructed outflow vessel in the submalleolar segment of the target limb planned for revascularization.
• 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

• Presence of life-threatening diseases or comorbidities with an expected life expectancy of less than 1 year.
• Concurrent participation in another interventional clinical trial requiring informed consent.
• Diagnosis of Alzheimer's disease.
• Hematologic disorders or known bleeding tendency.
• Contraindications to antiplatelet or anticoagulant therapy.
• Known allergy to contrast agents that cannot be managed with standard premedication (e.g., steroids).
• Deficiency or dysfunction of protein C, protein S, or antithrombin III (ATIII).
• New York Heart Association (NYHA) Class III or IV heart failure.
• Pregnancy or lactation.
• Prior suprapatellar or infrapatellar amputation of the target limb.
• Presence of aneurysm, perforation, dissection, or other target vessel injury requiring intervention.
• Presence of other comorbid conditions (unrelated to the index disease) that affect walking function.
• History of cardiovascular events within the past 3 months, including nonfatal myocardial infarction, unstable angina, stable angina, nonfatal ischemic stroke, or hemorrhagic stroke.
• Clinically significant liver or renal dysfunction, as determined by the investigator.
• Any other condition that, in the opinion of the investigator, would interfere with study treatment or functional assessments.