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This is a prospective, multicenter, observational study designed to evaluate the clinical outcomes of the Rangerâ„¢ 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB | Ranger drug-coated balloon group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-coated balloon | Device | Drug-coated balloon was used during the index procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Events (MAEs) | Composite of target lesion revascularization (TLR), target limb amputation, and all-cause mortality. | 1 month; 3 months; 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Late Lumen Loss (LLL) | Late lumen loss at the target lesion, measured by Quantitative Vascular Angiography (QVA). | 1 month; 3 months; 6 months |
| Postoperative Complications | Incidence of procedure-related adverse events, including arterial dissection, perforation, rupture, distal embolization, acute thrombosis, pseudoaneurysm, and hematoma formation. |
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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:
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Patients with below-the-knee (BTK) arterial lesions diagnosed with chronic limb-threatening ischemia (CLTI).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guangqi Chang | Contact | +8613922231628 | changgq@mail.sysu.edu.cn | |
| Haoliang Wu | Contact | wu18738957806@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangzhou | 510030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33948700 | Background | Del Giudice C, Galloula A, Tiercelin C, Vilfaillot A, Alsac JM, Messas E, Dean CL, Larger E, Sapoval M. "Ranger BTK" a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia. Cardiovasc Intervent Radiol. 2021 Jul;44(7):1017-1027. doi: 10.1007/s00270-021-02833-1. Epub 2021 May 4. | |
| 25523536 |
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| During procedure and hospitalization (up to 7 days post-procedure) |
| 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. | Baseline, 1 month; 3 months; 6 months |
| Rutherford Classification | Grading system (0-6) for evaluating the severity of peripheral artery disease (PAD) in the lower extremities. | Baseline, 1 month; 3 months; 6 months |
| Amputation-Free Survival (AFS) | Defined as survival without ipsilateral major amputation (above the ankle). | 1 month; 3 months; 6 months |
| Limb Salvage | Freedom from major (above-ankle) amputation in the target limb. | 1 month; 3 months; 6 months |
| Soga Y, Iida O, Takahara M, Hirano K, Suzuki K, Kawasaki D, Miyashita Y, Tsuchiya T. Two-year life expectancy in patients with critical limb ischemia. JACC Cardiovasc Interv. 2014 Dec;7(12):1444-9. doi: 10.1016/j.jcin.2014.06.018. |
| 27853158 | Background | Fowkes FG, Aboyans V, Fowkes FJ, McDermott MM, Sampson UK, Criqui MH. Peripheral artery disease: epidemiology and global perspectives. Nat Rev Cardiol. 2017 Mar;14(3):156-170. doi: 10.1038/nrcardio.2016.179. Epub 2016 Nov 17. |
| 28847660 | Background | Scully RE, Arnaoutakis DJ, DeBord Smith A, Semel M, Nguyen LL. Estimated annual health care expenditures in individuals with peripheral arterial disease. J Vasc Surg. 2018 Feb;67(2):558-567. doi: 10.1016/j.jvs.2017.06.102. Epub 2017 Aug 25. |
| 23915883 | Background | Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |