Chronic Limb Threatening Ischemia
Conditions
Keywords
chronic limb threatening ischemia, below the knee, drug-coated balloon
Brief 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).
Interventions
DEVICEdrug-coated balloon
Drug-coated balloon was used during the index procedure.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events (MAEs) | 1 month; 3 months; 6 months | Composite of target lesion revascularization (TLR), target limb amputation, and all-cause mortality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Late Lumen Loss (LLL) | 1 month; 3 months; 6 months | Late lumen loss at the target lesion, measured by Quantitative Vascular Angiography (QVA). |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactGuangqi Chang
Backup ContactHaoliang Wu
Outcome results
None listed