Comparing two types of balloons for treating arteriovenous graft stenosis in dialysis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized controlled clinical study aims to evaluate the effectiveness of a scoring balloon compared to a high-pressure balloon in treating stenosis in hemodialysis arteriovenous grafts. A total of 140 subjects will be recruited from seven clinical trial institutions, with participants randomly assigned to receive either the scoring balloon or the peripheral balloon for their treatment. Clinical follow-ups will occur at multiple intervals post-procedure to assess outcomes and optimize treatment strategies for this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Hemodialysis patients aged ≥18 and ≤80 years old, (Note: Hemodialysis patients in Singapore aged ≥ 21 and ≤80 years old);
2. AVG is mature and has successfully completed at least one hemodialysis treatment;
3. The target lesion is located in the AVG return vein and the venous side anastomosis;
4. The degree of stenosis of the target lesion is ≥50% (DSA visual inspection), and one of the following clinical indicators exists at the same time: Physical examination abnormalities include: open collateral veins, ipsilateral limb edema, changes in pulse characteristics, abnormal tremors, abnormal murmurs, etc.; Dialysis abnormalities include: increased venous pressure, new puncture difficulties, aspiration of thrombi, inability to reach target dialysis blood flow, prolonged haemostasis time after needle removal for 3 consecutive times, unexplained decrease in dialysis dose Kt/V (\>0.2 units), decrease in brachial artery blood flow (brachial artery blood flow \<650ml/min or decreased by 20% compared with the previous follow-up visit), etc.
5. The target lesion is primary or restenotic, consisting of one or more series of lesions, and the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤80mm ;
6. The patient voluntarily signs the informed consent form.

Exclusion Criteria:

1. The target lesion is located in the feeding artery, arterial anastomosis, artificial blood vessel puncture site, cephalic venous arch, thoracic outlet or central vein;
2. A stent has been implanted in any part of the access or there is ipsilateral central vein stenosis or occlusion that affects the function of the access;
3. Severely calcified lesions that are not expected to be dilatable with balloons;
4. Acute thrombosis or chronic total occlusion of AVG occurred at the time of enrolment;
5. The target lesion or any part of the vascular access has received PTA treatment within the last month;
6. There are thicker branch veins in the vein opening of the end-to-side anastomosis;
7. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
8. Patients known to be allergic to or intolerant to contrast media;
9. Patients receiving glucocorticoids or immunosuppressants;
10. The patient's life expectancy is less than 1 year;
11. Patients planning kidney transplantation or switching to peritoneal dialysis;
12. The degree of stenosis in the puncture point area is \>50%；
13. Patients with infection or other medical conditions that make the investigator think they are not suitable to participate in this study;
14. Those who have participated in clinical trials of other drugs or devices but have not completed them.

Where it's running

• Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• Beijing Tongren Hospital Affiliated to Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• South China Hospital of Shenzhen University
  Shenzhen, Guangdong, China Not yet recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Not yet recruiting
• The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Not yet recruiting

Study contacts

• Principal investigator: Pei Wang, MD — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Pei Wang, MD
• Email: wangpei146@hotmail.com
• Phone: +86 13523467291

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.