About this trial
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, multi-center cohort study.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Endovascular therapy