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NCT06422845

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

Sponsor: DK Medical Technology (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

328

Start Date

2024-09-30

Completion Date

2027-07

Last Updated

2025-01-09

Healthy Volunteers

Conditions

Arteriovenous Fistula Stenosis

Interventions

DEVICE

Dissolve AV Peripheral Scoring Drug-coated Balloon

Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon

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.

Locations (33)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Haidian Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Guangzhou First People's Hospital

Guanzhou, Guangdong, China

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The Eighth Affiliated Hospital, Sun Yat-sen University

Shenzhen, Guangdong, China

Liuzhou Traditional Chinese Medical Hospital

Liuchow, Guangxi, China

Foresea Life Insurance Guangxi Hospital

Nanning, Guangxi, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Tongji Hospital Affiliated To Tongji Medical College HUST

Wuhan, Hubei, China

Changsha Jieao Kidney Disease Hospital

Changsha, Hunan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Affiliated Hospital To Changchun University of Chinese Medicine

Changchun, Jilin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Qilu Hospital of Shandong University Dezhou Hospital

Dezhou, Shandong, China

Central Hospital Affiliated To Shandong First Medical University

Jinan, Shandong, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

People's Hospital of Rizhao

Rizhao, Shandong, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Sir Run Run Shaw Hospital Zhejiang University School of medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Jinhua Hospital of TCM

Jinhua, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Ürümqi, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (33)