Using a drug-coated balloon to treat narrowing in hemodialysis access points

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

This study is testing a special drug-coated balloon to see if it can safely improve blood flow in people with narrowed access points for hemodialysis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 328 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: DK Medical Technology (Suzhou) Co., Ltd. (Industry-sponsored)
• Locations: 33 sites (Hefei, Anhui and 32 other locations)
• Trial ID: NCT06422845 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of a Peripheral Scoring Drug-coated Balloon (SDCB) for treating hemodialysis arteriovenous fistula stenosis. It is a prospective, multi-center, single-arm study involving 328 participants who will undergo a procedure using the SDCB catheter. Follow-up assessments will occur at multiple intervals post-procedure to monitor the primary endpoint of target lesion primary patency at 6 months. The study aims to provide insights into the potential benefits of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with significant stenosis in their hemodialysis access points.

Not a fit: Patients with immature arteriovenous fistulas or those with less than 50% stenosis may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could improve the longevity and functionality of hemodialysis access points for patients.

How similar studies have performed: Previous studies have shown promise with drug-coated balloons in vascular interventions, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 32 other locations

• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• Beijing Haidian Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Guangzhou First People's Hospital — Guanzhou, Guangdong, China (Not_yet_recruiting)
• Huizhou Central People's Hospital — Huizhou, Guangdong, China (Not_yet_recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• The Eighth Affiliated Hospital, Sun Yat-sen University — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Liuzhou Traditional Chinese Medical Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• Foresea Life Insurance Guangxi Hospital — Nanning, Guangxi, China (Not_yet_recruiting)
• The Affiliated Cancer Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongji Hospital Affiliated To Tongji Medical College HUST — Wuhan, Hubei, China (Not_yet_recruiting)
• Changsha Jieao Kidney Disease Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• Hunan Provincial People's Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The Affiliated Hospital To Changchun University of Chinese Medicine — Changchun, Jilin, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University Dezhou Hospital — Dezhou, Shandong, China (Not_yet_recruiting)
• Central Hospital Affiliated To Shandong First Medical University — Jinan, Shandong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Shandong First Medical University — Jinan, Shandong, China (Not_yet_recruiting)
• Qingdao Municipal Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
• People's Hospital of Rizhao — Rizhao, Shandong, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (Not_yet_recruiting)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (Not_yet_recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Not_yet_recruiting)
• Affiliated Hospital of North Sichuan Medical College — Nanchong, Sichuan, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital Zhejiang University School of medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Jinhua Hospital of TCM — Jinhua, Zhejiang, China (Not_yet_recruiting)
• Taizhou Hospital of Zhejiang Province — Taizhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Ürümqi, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Yuzhu Wang, MD — Beijing Haidian Hospital
• Study coordinator: Yuzhu Wang, MD

Conditions Arteriovenous Fistula Stenosis; arteriovenous fistula stenosis; scoring; hemodialysis; drug-coated balloon