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Clinical Trials in China / NCT06422845
Recruiting Not applicable

Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis

NCT06422845 · tracked via the Priya Life Science China tracker
Sponsor
DK Medical Technology (Suzhou) Co., Ltd.
Phase
Not applicable
Started
2024-09-30
Last updated
2025-01-09

Condition(s) studied

Arteriovenous Fistula Stenosis

Investigational drug(s) / intervention(s)

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)

Trial sites (33)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT06422845 on ClinicalTrials.gov ↗ ← All trials in China