A Prospective, Multicenter, Single-Arm Target Value Clinical Study to Evaluate the Safety and Effectiveness of Peripheral Scoring Drug-coated Balloon Dilation Catheter in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age ≥ 18 and ≤ 80 years old;

• The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;

• The target lesion is located at the AVF/AVG return vein and venous side anastomosis;

• Hemodynamically significant AVF/AVG return vein stenosis ≥ 50% as assessed by ultrasound or contrast imaging, and any of the following clinical symptoms, signs or indicators are present, including significant increase in venous pressure during dialysis, abnormal physical examination, decreased pump-controlled blood flow, decreased adequacy of dialysis, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up visit, etc.;

• The target lesion is a primary or restenotic lesion, consisting of one or more tandem lesions (if the total length of adjacent tandem lesions is ≤ 60 mm, it can be considered a single target lesion);

• Visual inspection of the reference blood vessel diameter of the target lesion is between 4.0-8.0mm, and the total length of the target lesion is ≤ 60mm;

• The patient voluntarily signs the informed consent form.

Locations
Other Locations
China
Beijing Haidian Hospital
RECRUITING
Beijing
The Affiliated Hospital To Changchun University of Chinese Medicine
NOT_YET_RECRUITING
Changchun
Changsha Jieao Kidney Disease Hospital
NOT_YET_RECRUITING
Changsha
Hunan Provincial People's Hospital
NOT_YET_RECRUITING
Changsha
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital Sichuan University
NOT_YET_RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Qilu Hospital of Shandong University Dezhou Hospital
NOT_YET_RECRUITING
Dezhou
Guangzhou First People's Hospital
NOT_YET_RECRUITING
Guanzhou
The Affiliated Cancer Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Sir Run Run Shaw Hospital Zhejiang University School of medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The Second Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Huizhou Central People's Hospital
NOT_YET_RECRUITING
Huizhou
Central Hospital Affiliated To Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Jinhua Hospital of TCM
NOT_YET_RECRUITING
Jinhua
Liuzhou Traditional Chinese Medical Hospital
NOT_YET_RECRUITING
Liuzhou
Mianyang Central Hospital
NOT_YET_RECRUITING
Mianyang
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Affiliated Hospital of North Sichuan Medical College
NOT_YET_RECRUITING
Nanchong
Foresea Life Insurance Guangxi Hospital
NOT_YET_RECRUITING
Nanning
Qingdao Municipal Hospital
NOT_YET_RECRUITING
Qingdao
People's Hospital of Rizhao
NOT_YET_RECRUITING
Rizhao
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
The Eighth Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITING
Shenzhen
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
Taizhou Hospital of Zhejiang Province
NOT_YET_RECRUITING
Taizhou
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Ürümqi
Tongji Hospital Affiliated To Tongji Medical College HUST
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yuzhu Wang, MD
wyz4417@126.com
18701387950
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2027-07
Participants
Target number of participants: 328
Treatments
Experimental: Dissolve AV Peripheral Scoring Drug-coated Balloon
Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter
Related Therapeutic Areas
Sponsors
Leads: DK Medical Technology (Suzhou) Co., Ltd.

This content was sourced from clinicaltrials.gov