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

NCT07014475 | Not Yet Recruiting DMC

• 1 other identifier: [2025]194
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Limb Threatening Ischemia

Keywords

chronic limb threatening ischemia; below the knee; drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• Major Adverse Events (MAEs)

  Composite of target lesion revascularization (TLR), target limb amputation, and all-cause mortality.

  1 month; 3 months; 6 months

Secondary Outcomes (6)

• Late Lumen Loss (LLL)

  1 month; 3 months; 6 months

• Postoperative Complications

  During procedure and hospitalization (up to 7 days post-procedure)

• Quality of Life (QoL)

  Baseline, 1 month; 3 months; 6 months

• Rutherford Classification

  Baseline, 1 month; 3 months; 6 months

• Amputation-Free Survival (AFS)

  1 month; 3 months; 6 months

Study Arms (1)

DCB

Ranger drug-coated balloon group

Device: drug-coated balloon

Interventions

drug-coated balloon DEVICE

Drug-coated balloon was used during the index procedure.

DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with below-the-knee (BTK) arterial lesions diagnosed with chronic limb-threatening ischemia (CLTI).

You may qualify if:

• 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)
• 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:
• Unobstructed blood flow in the suprapopliteal access pathway (including inflow vessels that have been recanalized via staged or concurrent endovascular intervention or hybrid surgery).

You may not qualify if:

• 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.
• Contraindications to antiplatelet or anticoagulant therapy.
• Known allergy to contrast agents that cannot be managed with standard premedication (e.g., steroids).
• Deficiency or dysfunction of protein C, protein S, or antithrombin III (ATIII).
• New York Heart Association (NYHA) Class III or IV heart failure.
• Pregnancy or lactation.
• Prior suprapatellar or infrapatellar amputation of the target limb.
• Presence of aneurysm, perforation, dissection, or other target vessel injury requiring intervention.
• Presence of other comorbid conditions (unrelated to the index disease) that affect walking function.
• History of cardiovascular events within the past 3 months, including nonfatal myocardial infarction, unstable angina, stable angina, nonfatal ischemic stroke, or hemorrhagic stroke.
• Clinically significant liver or renal dysfunction, as determined by the investigator.
• Any other condition that, in the opinion of the investigator, would interfere with study treatment or functional assessments.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangzhou, 510030, China

Location

Related Publications (5)

• 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.

  PMID: 33948700 BACKGROUND

• 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.

  PMID: 25523536 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.

  PMID: 27853158 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.

  PMID: 28847660 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.

  PMID: 23915883 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Guangqi Chang

CONTACT

+8613922231628; changgq@mail.sysu.edu.cn

Haoliang Wu

CONTACT

wu18738957806@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)