Status:
RECRUITING
Effectiveness of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
Lead Sponsor:
RenJi Hospital
Conditions:
Hemodialysis Access Failure
Eligibility:
All Genders
18-75 years
Brief Summary
This study was aimed at comparing the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous segment stenosis of autologous arteriovenous fistulas.This is a prospective...
Detailed Description
The study will recruit 180 patients with venous segment stenosis of autologous arteriovenous fistulas at multiple centers from June 2024 to December 2025. Patients will be divided into two cohorts bas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06493292
Start Date
June 1 2024
End Date
December 1 2026
Last Update
July 9 2024
Active Locations (3)
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1
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
2
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
3
Renji Hospital
Shanghai, Shanghai Municipality, China