Status:
RECRUITING
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Lead Sponsor:
DK Medical Technology (Suzhou) Co., Ltd.
Conditions:
Arteriovenous Graft Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is su...
Eligibility Criteria
Inclusion
- Hemodialysis patients aged ≥18 and ≤80 years old, (Note: Hemodialysis patients in Singapore aged ≥ 21 and ≤80 years old);
- AVG is mature and has successfully completed at least one hemodialysis treatment;
- The target lesion is located in the AVG return vein and the venous side anastomosis;
- 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.
- 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 ;
- The patient voluntarily signs the informed consent form.
Exclusion
- The target lesion is located in the feeding artery, arterial anastomosis, artificial blood vessel puncture site, cephalic venous arch, thoracic outlet or central vein;
- 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;
- Severely calcified lesions that are not expected to be dilatable with balloons;
- Acute thrombosis or chronic total occlusion of AVG occurred at the time of enrolment;
- The target lesion or any part of the vascular access has received PTA treatment within the last month;
- There are thicker branch veins in the vein opening of the end-to-side anastomosis;
- Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
- Patients known to be allergic to or intolerant to contrast media;
- Patients receiving glucocorticoids or immunosuppressants;
- The patient's life expectancy is less than 1 year;
- Patients planning kidney transplantation or switching to peritoneal dialysis;
- The degree of stenosis in the puncture point area is \>50%；
- Patients with infection or other medical conditions that make the investigator think they are not suitable to participate in this study;
- Those who have participated in clinical trials of other drugs or devices but have not completed them.
Key Trial Info
Start Date :
August 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06503692
Start Date
August 13 2024
End Date
December 1 2026
Last Update
January 9 2025
Active Locations (7)
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1
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
3
South China Hospital of Shenzhen University
Shenzhen, Guangdong, China
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China