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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY

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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Renji Hospital
RECRUITING
Shanghai
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
RuZhou Cao
caorzh@126.com
+86 18616752813
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 180
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov