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

• drug-coated balloon (Device): Drug-coated balloon was used during the index procedure.

Primary outcomes

• Major Adverse Events (MAEs) [1 month; 3 months; 6 months]: Composite of target lesion revascularization (TLR), target limb amputation, and all-cause mortality.

Secondary outcomes

• Late Lumen Loss (LLL) [1 month; 3 months; 6 months]: Late lumen loss at the target lesion, measured by Quantitative Vascular Angiography (QVA).
• Postoperative Complications [During procedure and hospitalization (up to 7 days post-procedure)]: Incidence of procedure-related adverse events, including arterial dissection, perforation, rupture, distal embolization, acute thrombosis, pseudoaneurysm, and hematoma formation.
• Quality of Life (QoL) [Baseline, 1 month; 3 months; 6 months]: Assessed using the VascuQol-25 questionnaire, scored on a scale from 1 (worst) to 7 (best). Quality-adjusted life years (QALYs) calculated by multiplying the health-related quality of life (HRQoL) index score by time spent in each health state.
• Rutherford Classification [Baseline, 1 month; 3 months; 6 months]: Grading system (0-6) for evaluating the severity of peripheral artery disease (PAD) in the lower extremities.
• Amputation-Free Survival (AFS) [1 month; 3 months; 6 months]: Defined as survival without ipsilateral major amputation (above the ankle).
• Limb Salvage [1 month; 3 months; 6 months]: Freedom from major (above-ankle) amputation in the target limb.

Sex: All, ages: 18 Years to any

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.

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