DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis

Launched by RENJI HOSPITAL · Jul 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different types of balloons used in a procedure to treat narrowing (stenosis) in arteriovenous fistulas, which are important for patients undergoing hemodialysis. The trial aims to find out if drug-coated balloons are more effective and safer than cutting balloons in preventing re-narrowing of the fistula. Participants will be monitored for any medical issues that may arise during the treatment with either type of balloon.

To be eligible for this trial, participants should be between 18 and 75 years old, have a functioning arteriovenous fistula in their upper limb that has been confirmed to have significant narrowing, and have already had at least one hemodialysis session. They should also be willing to understand the trial's purpose and follow the required check-ups. This study is currently recruiting participants, and it’s essential for anyone interested to discuss their specific health situation with their doctor to see if they qualify.

Gender

ALL

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 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.