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

A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

This study is testing whether a special type of balloon or a high-pressure balloon works better for treating narrowing in blood vessels for people on dialysis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: DK Medical Technology (Suzhou) Co., Ltd. (Industry-sponsored)
• Locations: 7 sites (Beijing, Beijing Municipality and 6 other locations)
• Trial ID: NCT06503692 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are hemodialysis patients aged 18 to 80 years with significant stenosis in their arteriovenous grafts.

Not a fit: Patients with less than 50% stenosis or those who do not meet the specific clinical indicators for intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with arteriovenous graft stenosis, enhancing their dialysis experience and outcomes.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in using balloon angioplasty techniques for vascular interventions.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 6 other locations

• 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)
• Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• National University Hospital of Singapore — Singapore, Singapore (Not_yet_recruiting)

Study contacts

• Principal investigator: Pei Wang, MD — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Pei Wang, MD

Conditions Arteriovenous Graft Stenosis; Scoring Balloon; Angioplasty