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).
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)
Outflow Tract Requirement: At least one direct or indirect, unobstructed outflow vessel in the submalleolar segment of the target limb planned for revascularization.
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.
Patients with below-the-knee (BTK) arterial lesions diagnosed with chronic limb-threatening ischemia (CLTI).
Cohort
Prospective
drug-coated balloon
DeviceDrug-coated balloon was used during the index procedure.
Major Adverse Events (MAEs)
Composite of target lesion revascularization (TLR), target limb amputation, and all-cause mortality.
Late Lumen Loss (LLL)
Late lumen loss at the target lesion, measured by Quantitative Vascular Angiography (QVA).
Postoperative Complications
Incidence of procedure-related adverse events, including arterial dissection, perforation, rupture, distal embolization, acute thrombosis, pseudoaneurysm, and hematoma formation.
Quality of Life (QoL)
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
Grading system (0-6) for evaluating the severity of peripheral artery disease (PAD) in the lower extremities.
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