AzTrials
AzTrials

Chronic Limb Threatening IschemiaNCT07014475

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

An observational study of Chronic Limb Threatening Ischemia, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Limb Threatening Ischemia
What is being tested?
drug-coated balloon
Type of treatment
Medical device
How many people
700 participants
Where
1 siteChina
Study dates
30 Jun 2025to 1 Jan 2029
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guangqi Chang contact

+8613922231628

changgq@mail.sysu.edu.cn

Haoliang Wu contact

wu18738957806@126.com

China1 site

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangzhou, 510030

    Guangqi Chang, +8613922231628, changgq@mail.sysu.edu.cn

Other trials in China

About this study

Official title: Efficacy of the Ranger Drug-Coated Balloon in Treating Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia

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).

Being tested
drug-coated balloon
Keywords
chronic limb threatening ischemia, below the knee, drug-coated balloon
Medical subject headings
Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • drug-coated balloonDevice

    Drug-coated balloon was used during the index procedure.

Study groups in NCT07014475
Study groupRoleWhat they receive
DCBRanger drug-coated balloon group
Receives: Device: drug-coated balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Events (MAEs)

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

    Measured: 1 month; 3 months; 6 months

Secondary outcomes (6)

  1. Late Lumen Loss (LLL)

    Late lumen loss at the target lesion, measured by Quantitative Vascular Angiography (QVA).

    Measured: 1 month; 3 months; 6 months

  2. Postoperative Complications

    Incidence of procedure-related adverse events, including arterial dissection, perforation, rupture, distal embolization, acute thrombosis, pseudoaneurysm, and hematoma formation.

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

  3. 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.

    Measured: Baseline, 1 month; 3 months; 6 months

  4. Rutherford Classification

    Grading system (0-6) for evaluating the severity of peripheral artery disease (PAD) in the lower extremities.

    Measured: Baseline, 1 month; 3 months; 6 months

  5. Amputation-Free Survival (AFS)

    Defined as survival without ipsilateral major amputation (above the ankle).

    Measured: 1 month; 3 months; 6 months

  6. Limb Salvage

    Freedom from major (above-ankle) amputation in the target limb.

    Measured: 1 month; 3 months; 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2025
  2. Study start30 Jun 2025 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion1 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
700 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07014475
Sponsor's protocol ID
[2025]194
Status last verified
Jun 2025
First submitted
3 Jun 2025
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33948700

  • 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.

    PubMed 25523536

  • 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.

    PubMed 27853158

  • 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.

    PubMed 28847660

  • 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.

    PubMed 23915883

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Limb Threatening Ischemia, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Guangqi Chang (+8613922231628, changgq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Events (MAEs) (time frame: 1 month; 3 months; 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07014475, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in