Actively Recruiting
Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis
Led by DK Medical Technology (Suzhou) Co., Ltd. · Updated on 2025-01-09
328
Participants Needed
33
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multi-center, single-arm target value clinical study to study the safety and effectiveness of Peripheral Scoring Drug-coated Balloon dilatation catheters in the treatment of hemodialysis arteriovenous fistula stenosis.
CONDITIONS
Official 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 or graft with at least one successful hemodialysis session
- Target lesion located at the return vein and venous side anastomosis of AVF/AVG
- Hemodynamically significant stenosis of 50% or more confirmed by ultrasound or contrast imaging with related clinical symptoms
- Target lesion may be primary or restenotic and include one or more tandem lesions with total length up to 60 mm
- Reference blood vessel diameter between 4.0 and 8.0 mm; total lesion length up to 60 mm
- Voluntary signed informed consent
You will not qualify if you...
- Women of childbearing age without a negative pregnancy test or who are breastfeeding
- Major surgery within 30 days before enrollment
- Calcified lesions unlikely to expand with balloons
- Thrombosis at the stenosis site
- Lesions located at 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 transplant or switch to peritoneal dialysis
- Vascular access or systemic active infection
- Participation in unfinished clinical trials of other drugs or devices
- Other medical conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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