Actively Recruiting
Multicenter Randomized Clinical Trial Comparing Scoring Balloon and High Pressure Balloon Catheters for Treating Arteriovenous Graft Stenosis in Hemodialysis Patients
Led by DK Medical Technology (Suzhou) Co., Ltd. · Updated on 2025-01-09
140
Participants Needed
7
Research Sites
120 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating patients with hemodialysis arteriovenous graft stenosis to compare the effectiveness of a scoring balloon versus a high pressure balloon in treating these lesions. This multicenter, prospective, randomized controlled clinical study aims to provide data that can optimize treatment for this condition. The study involves seven clinical trial sites and plans to include a total of 140 participants. Participants will be randomly assigned to receive treatment either with the DKutting PTA Scoring Balloon Dilatation Catheter, which has scoring elements designed to expand at lower pressure by focusing force along specific points, or with a peripheral balloon catheter that inflates to a known diameter at a specified pressure. After the procedure, clinical follow-up visits are scheduled at 5 days, 3 months, 6 months, and 12 months to monitor progress. During the study, participants will undergo evaluations to measure the primary outcome of target lesion primary patency at 6 months after the procedure. Researchers will conduct clinical assessments including physical exams and dialysis monitoring. Safety and treatment effectiveness will be tracked through these follow-up visits over one year, ensuring comprehensive observation of the participants' vascular access status and treatment outcomes.
CONDITIONS
Official Title
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hemodialysis patients aged 18 to 80 years (in Singapore, aged 21 to 80 years)
- Mature arteriovenous graft with at least one successful hemodialysis treatment
- Target lesion located in the arteriovenous graft return vein and venous anastomosis
- Target lesion stenosis of 50% or more with related clinical indicators such as abnormal physical exam findings or dialysis abnormalities
- Target lesion is primary or restenotic with reference vessel diameter between 4.0 and 8.0 mm and total lesion length up to 80 mm
- Voluntary signed informed consent form
You will not qualify if you...
- Target lesion located in feeding artery, arterial anastomosis, artificial puncture site, cephalic venous arch, thoracic outlet, or central vein
- Presence of stent in access or ipsilateral central vein stenosis or occlusion affecting access function
- Severely calcified lesions unlikely to be dilatable by balloons
- Acute thrombosis or chronic total occlusion of arteriovenous graft at enrollment
- PTA treatment on target lesion or vascular access within last month
- Thicker branch veins at vein opening of end-to-side anastomosis
- Major surgery within 30 days before study inclusion
- Known allergy or intolerance to contrast media
- Current treatment with glucocorticoids or immunosuppressants
- Life expectancy less than 1 year
- Planned kidney transplantation or switch to peritoneal dialysis
- Stenosis over 50% at puncture point area
- Infection or other medical conditions deemed unsuitable by investigator
- Participation in other drug or device clinical trials not completed
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Not Yet Recruiting
3
South China Hospital of Shenzhen University
Shenzhen, Guangdong, China
Not Yet Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Not Yet Recruiting
5
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Not Yet Recruiting
6
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
7
National University Hospital of Singapore
Singapore, Singapore
Not Yet Recruiting
Research Team
P
Pei Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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