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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Haidian Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet 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

Study contacts

• Principal investigator: Yuzhu Wang, MD — Beijing Haidian Hospital
• Study coordinator: Yuzhu Wang, MD
• Email: wyz4417@126.com
• Phone: 18701387950

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Velocity pAVF system for creating dialysis fistulas through a small skin puncture

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• Comparing drug-coated balloons and cutting balloons for treating arteriovenous fistula stenosis

  This study is testing whether drug-coated balloons or cutting balloons work better and are safer for treating narrowing in arteriovenous fistulas in patients.

  Recruiting at 3 sites RenJi Hospital · Zhengzhou, Henan and 2 other locations · NCT06527963

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.