Dissolve AV Peripheral Scoring Drug-coated Balloon
Dissolve AV Peripheral Scoring Drug-coated Balloon: Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 and ≤ 80 years old;
2. The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
3. The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
4. 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.;
5. 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);
6. 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;
7. The patient voluntarily signs the informed consent form.
Exclusion Criteria:
1. Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
2. Patients who have undergone major surgical treatment within 30 days before inclusion in the study;
3. Calcified lesions that are not expected to be expandable with balloons;
4. Patients with thrombosis at the access stenosis site;
5. The target lesion is located at the blood supply artery and arterial anastomosis;
6. Patients known to be allergic to or intolerant to contrast media and paclitaxel;
7. The patient's life expectancy is less than 2 years;
8. Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;
9. Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;
10. Vascular access infection or systemic active infection;
11. Those who have participated in unfinished clinical trials of other drugs or devices;
12. Patients with other medical conditions that the investigator believes are not suitable to participate in this study.
Primary outcome measure(s)
Target Lesion Primary Patency (TLPP) at 6 months post-procedure — 6 months post-procedure Target Lesion Primary Patency is defined as freedom from clinically driven Target Lesion Failure (TLF) (including +/-5mm proximal or distal of the target lesion) or Vascular Access Thrombosis.
TLF is defined as the presence of at least one clinical symptom, sign or indicator (defined according to the NKF-K/DOQI guideline) due to target lesion stenosis (≥ 50% stenosis of the target lesion assessed by contrast angiography or ultrasound), including a significant increase in venous pressure during dialysis, high blood pressure, abnormal physical examination, decreased pump-controlled blood flow, decreased dialysis adequacy, brachial artery blood flow \< 600 ml/min or decreased by 25% compared with the previous follow-up, etc.
Trial sites (33)
Facility
City
Region
Status
The Second Hospital of Anhui Medical University
Hefei
Anhui
Not Yet Recruiting
Beijing Haidian Hospital
Beijing
Beijing Municipality
Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
Not Yet Recruiting
Guangzhou First People's Hospital
Guanzhou
Guangdong
Not Yet Recruiting
Huizhou Central People's Hospital
Huizhou
Guangdong
Not Yet Recruiting
Peking University Shenzhen Hospital
Shenzhen
Guangdong
Not Yet Recruiting
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen
Guangdong
Not Yet Recruiting
Liuzhou Traditional Chinese Medical Hospital
Liuzhou
Guangxi
Not Yet Recruiting
Foresea Life Insurance Guangxi Hospital
Nanning
Guangxi
Not Yet Recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang
Guizhou
Not Yet Recruiting
Henan Provincial People's Hospital
Zhengzhou
Henan
Not Yet Recruiting
Tongji Hospital Affiliated To Tongji Medical College HUST
Wuhan
Hubei
Not Yet Recruiting
Changsha Jieao Kidney Disease Hospital
Changsha
Hunan
Not Yet Recruiting
Hunan Provincial People's Hospital
Changsha
Hunan
Not Yet Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Hunan
Not Yet Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
The Affiliated Hospital To Changchun University of Chinese Medicine
Changchun
Jilin
Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Not Yet Recruiting
Qilu Hospital of Shandong University Dezhou Hospital
Dezhou
Shandong
Not Yet Recruiting
Central Hospital Affiliated To Shandong First Medical University
Jinan
Shandong
Not Yet Recruiting
The First Affiliated Hospital of Shandong First Medical University
Jinan
Shandong
Not Yet Recruiting
Qingdao Municipal Hospital
Qingdao
Shandong
Not Yet Recruiting
People's Hospital of Rizhao
Rizhao
Shandong
Not Yet Recruiting
Shanxi Bethune Hospital
Taiyuan
Shanxi
Not Yet Recruiting
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
Chengdu
Sichuan
Not Yet Recruiting
West China Hospital Sichuan University
Chengdu
Sichuan
Not Yet Recruiting
Mianyang Central Hospital
Mianyang
Sichuan
Not Yet Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong
Sichuan
Not Yet Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of medicine
Hangzhou
Zhejiang
Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Zhejiang
Not Yet Recruiting
Jinhua Hospital of TCM
Jinhua
Zhejiang
Not Yet Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou
Zhejiang
Not Yet Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Ürümqi
Not Yet Recruiting
More DK Medical Technology (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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