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At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
180 (estimated)
Sponsor
RenJi Hospital · Other
Who this trial is looking for
This trial is looking for adults with a type of blood vessel narrowing in their arm due to hemodialysis access. Participants will receive either a cutting balloon or a drug-coated balloon to see which treatment works better and what issues may arise.
Are You a Good Fit for This Trial?
Rules you outCoagulopathyVasculitis
You may be able to join if
I am between 18 and 75 years old.
I have a mature upper limb arteriovenous fistula (AVF).
I have had at least one hemodialysis session.
I have a venous narrowing (stenosis) that is confirmed to be 50% or more.
I have certain problems during dialysis, like high venous pressure.
I can give my informed consent to participate.
I am willing to follow up as required by the trial.
You may not be able to join if
My narrowing is in the artery section of the AVF.
I have had a stent placed in my AVF.
I have signs of a serious central vein blockage.
I have two or more narrow areas in my AVF.
I had a blood clot in my AVF or related treatment in the past 30 days.
I plan to have surgery on my AVF in the next 30 days.
I have an infection in my AVF or another active systemic infection.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are:
1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons?
2. What medical problems do participants have when receiving treatment with drug-co…
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulas.The main questions it aims to answer are:
1. Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons?
2. What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons?
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Subjects aged between 18 and 75 years. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.
Target lesion must be located in the venous segment of the upper limb AVF. Doppler ultrasound confirms that t…
Inclusion Criteria:
Subjects aged between 18 and 75 years. Subjects possess a mature upper limb autologous arteriovenous fistula (AVF) and have undergone at least one hemodialysis session.
Target lesion must be located in the venous segment of the upper limb AVF. Doppler ultrasound confirms that the target lesion stenosis is ≥50%, accompanied by at least one of the following clinical manifestations: elevated venous pressure during dialysis, abnormal fistula signs, significant reduction in blood flow (\<200ml/min).
Guidewire and balloon successfully pass through the lesion and complete dilation. 6.Subjects or their legal representatives must understand the purpose of the trial, voluntarily participate in the clinical trial, and sign an informed consent form, while also being willing to adhere to the specific follow-up schedules set by this trial.
Exclusion Criteria:
Target lesion located in the arterial segment or anastomosis of the AVF. Target lesion located in the lower limb AVF. Subjects with previous stent implantation in the AVF. Patients diagnosed with symptomatic central venous occlusive disease: AVF flow reduction accompanied by swelling of the ipsilateral limb, chest, or facial area, with DSA confirmation of central venous occlusive disease.
Subjects with two or more target lesions in the AVF (when two stenoses are less than 3 cm apart, they are considered as one target lesion).
Subjects with acute thrombosis in the AVF or who have undergone AVF thrombolysis or thrombectomy within the past 30 days.
Subjects who have undergone or plan to undergo surgical intervention on the AVF within 30 days.
Subjects with AVF infection or concurrent systemic active infection. Subjects planning renal transplantation or switching to peritoneal dialysis within the next 12 months.
Subjects with diseases causing coagulopathy, such as thrombocytopenic purpura. Subjects undergoing immunotherapy or suspected/diagnosed with vasculitis. Subjects with allergies or contraindications to heparin or contrast agents. Subjects who are pregnant or breastfeeding. Subjects with a life expectancy of less than 12 months.
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