Clinical trial NCT07014475: Efficacy of the Ranger Drug-Coated Balloon in Treating BTK Lesions in Patients With CLTI
Official title: Efficacy of the Ranger Drug-Coated Balloon in Treating Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Limb Threatening Ischemia
Keywords: chronic limb threatening ischemia
below the knee
drug-coated balloon
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with below-the-knee (BTK) arterial lesions diagnosed with chronic limb-threatening ischemia (CLTI).

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Major Adverse Events (MAEs)
timeFrame: 1 month; 3 months; 6 months
Secondary outcomes:
measure: Late Lumen Loss (LLL)
timeFrame: 1 month; 3 months; 6 months
measure: Postoperative Complications
timeFrame: During procedure and hospitalization (up to 7 days post-procedure)
measure: Quality of Life (QoL)
timeFrame: Baseline, 1 month; 3 months; 6 months
measure: Rutherford Classification
timeFrame: Baseline, 1 month; 3 months; 6 months
measure: Amputation-Free Survival (AFS)
timeFrame: 1 month; 3 months; 6 months
measure: Limb Salvage
timeFrame: 1 month; 3 months; 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangzhou
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.