Actively Recruiting
Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter for Hemodialysis Arteriovenous Fistula Stenosis in a Prospective Multicenter Study
Led by DK Medical Technology (Suzhou) Co., Ltd. · Updated on 2025-01-09
328
Participants Needed
33
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in treating stenosis of arteriovenous fistulas used for hemodialysis. This prospective, multi-center, single-arm clinical study plans to enroll 328 participants who have mature arteriovenous fistulas or grafts with significant narrowing. The study aims to measure how well the treated blood vessel remains open, focusing on the primary patency of the target lesion six months after the procedure. Participants will receive treatment using the Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter during a surgical procedure. After treatment, participants will have follow-up visits within 5 days, then at 1 month, 6 months, and later at 12, 18, and 24 months to monitor the treated area. The primary goal is to assess the blood vessel's openness at 6 months, with additional checks extending up to two years to evaluate longer-term outcomes. During the study, participants will undergo various assessments including Doppler ultrasound to measure blood flow and detect restenosis, evaluations of clinical success shortly after the procedure, and checks for the need for further revascularization treatments. Safety and technical success of the device will also be monitored immediately after the intervention. The total participation time spans up to 24 months, allowing detailed observation of the device's performance and the participant's vascular health over time.
CONDITIONS
Brief Title
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Mature arteriovenous fistula (AVF) or arteriovenous graft (AVG) that has been successfully used for hemodialysis at least once
- Target lesion located at the AVF/AVG return vein and venous side anastomosis
- Hemodynamically significant AVF/AVG return vein stenosis of 50% or more with clinical symptoms or indicators such as increased venous pressure during dialysis or decreased blood flow
- Target lesion may be primary or restenotic, with total length of adjacent tandem lesions 60 mm or less
- Reference blood vessel diameter of target lesion between 4.0 and 8.0 mm, total lesion length 60 mm or less
- Voluntary signing of informed consent form
You will not qualify if you...
- Women of childbearing age who are pregnant or breastfeeding
- Major surgical treatment within 30 days prior to study inclusion
- Calcified lesions unlikely to expand with balloons
- Thrombosis at access stenosis site
- Target lesion located in blood supply artery or arterial anastomosis
- Known allergy or intolerance to contrast media or paclitaxel
- Life expectancy less than 2 years
- Systemic lupus erythematosus or ANCA-associated small vessel vasculitis
- History of kidney transplantation or planned kidney transplant or switch to peritoneal dialysis
- Vascular access infection or systemic active infection
- Participation in unfinished clinical trials of other drugs or devices
- Other medical conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day procedure
Participants undergo a surgical procedure using the Peripheral Scoring Drug-coated Balloon dilation catheter to treat arteriovenous fistula stenosis.
1 procedure visit (in-person)
Duration - 24 months post-procedure
Participants are monitored after the procedure with visits to evaluate safety and effectiveness.
Visits within 5 days, at 1 month, 6 months, 12 months, 18 months, and 24 months post-procedure
Trial Site Locations
Total: 33 locations
1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
2
Beijing Haidian Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Not Yet Recruiting
4
Guangzhou First People's Hospital
Guanzhou, Guangdong, China
Not Yet Recruiting
5
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Not Yet Recruiting
6
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Not Yet Recruiting
7
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China
Not Yet Recruiting
8
Liuzhou Traditional Chinese Medical Hospital
Liuzhou, Guangxi, China
Not Yet Recruiting
9
Foresea Life Insurance Guangxi Hospital
Nanning, Guangxi, China
Not Yet Recruiting
10
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
11
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
12
Tongji Hospital Affiliated To Tongji Medical College HUST
Wuhan, Hubei, China
Not Yet Recruiting
13
Changsha Jieao Kidney Disease Hospital
Changsha, Hunan, China
Not Yet Recruiting
14
Hunan Provincial People's Hospital
Changsha, Hunan, China
Not Yet Recruiting
15
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
16
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
17
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun, Jilin, China
Not Yet Recruiting
18
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Not Yet Recruiting
19
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou, Shandong, China
Not Yet Recruiting
20
Central Hospital Affiliated To Shandong First Medical University
Jinan, Shandong, China
Not Yet Recruiting
21
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
Not Yet Recruiting
22
Qingdao Municipal Hospital
Qingdao, Shandong, China
Not Yet Recruiting
23
People's Hospital of Rizhao
Rizhao, Shandong, China
Not Yet Recruiting
24
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Not Yet Recruiting
25
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Not Yet Recruiting
26
West China Hospital Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
27
Mianyang Central Hospital
Mianyang, Sichuan, China
Not Yet Recruiting
28
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China
Not Yet Recruiting
29
Sir Run Run Shaw Hospital Zhejiang University School of medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
30
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
31
Jinhua Hospital of TCM
Jinhua, Zhejiang, China
Not Yet Recruiting
32
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Not Yet Recruiting
33
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Ürümqi, China
Not Yet Recruiting
Research Team
Y
Yuzhu Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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