Clinical trial NCT06503692: Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Official title: A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arteriovenous Graft Stenosis
Keywords: Arteriovenous Graft Stenosis
Scoring Balloon
Angioplasty
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 superior to the high pressure balloon in treating such lesions, so as to provide a basis for optimizing the treatment of such lesions.

This study will be conducted in seven (7) clinical trial institutions, with a total of 140 subjects included. After randomization, the subjects will use either the scoring balloon dilatation catheter, developed and produced by DK Medical Technology Co., Ltd., or the peripheral balloon dilatation catheter for surgical treatment. Clinical follow-up will be carried out within 5 days, 3 months, 6 months, and 12 months after the procedure.


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.

Primary outcomes:
measure: Target Lesion Primary Patency (TLPP) at 6 months post-procedure
timeFrame: 6 months
Secondary outcomes:
measure: Target Lesion Primary Patency (TLPP) at 12 months post-procedure
timeFrame: 12 months
measure: Access Circuit Primary Patency (ACPP) at 6 and 12 months post-procedure
timeFrame: 6, 12 months post-procedure
measure: Access Circuit Secondary Patency (ACSP) 6 and 12 months after surgery
timeFrame: 6, 12 months post-procedure
measure: Acute Lumen Gain
timeFrame: During the procedure
measure: Technical Success
timeFrame: 0-5 days post-procedure
measure: Clinical Success
timeFrame: 0-5 days post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: South China Hospital of Shenzhen University
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Singapore
country: Singapore
facility: National University Hospital of Singapore
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Pei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: