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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Fistula Stenosis
• Intervention / Treatment: Device: Dissolve AV Peripheral Scoring Drug-coated Balloon

Detailed Description

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 (SDCB) in the treatment of hemodialysis arteriovenous fistula stenosis. A total of 328 participants will be enrolled across multiple clinical trial sites. Participants will undergo a surgical procedure using a peripheral scoring drug-coated balloon dilation catheter, with follow-up within 5 days, at 1 month, and 6 months after the procedure, then at 12, 18, and 24 months post-procedure. The target lesion primary patency (TLPP) at 6 months post-procedure is the defined primary endpoint to evaluate the safety and effectiveness of the peripheral scoring drug balloon dilatation catheter.

• Study Type: Interventional
• Enrollment (Estimated): 328
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuzhu Wang, MD; Phone Number: 18701387950; Email: wyz4417@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The Second Hospital of Anhui Medical University
      • Contact: Liang Yuan
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Haidian Hospital
      • Contact: Yuzhu Wang, MD; Phone Number: 18701387950; Email: wyz4417@126.com
  • Chongqing
    • Chongqing, Chongqing, China
      • Not yet recruiting
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Qining Fu
  • Guangdong
    • Guanzhou, Guangdong, China
      • Not yet recruiting
      • Guangzhou First People's Hospital
      • Contact: Riguang Liu
    • Huizhou, Guangdong, China
      • Not yet recruiting
      • Huizhou Central People's Hospital
      • Contact: Qiming Chen
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • The Eighth Affiliated Hospital, Sun Yat-sen University
      • Contact: Tiecheng Yang
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Peking University Shenzhen Hospital
      • Contact: Wei Liang
  • Guangxi
    • Liuzhou, Guangxi, China
      • Not yet recruiting
      • Liuzhou Traditional Chinese Medical Hospital
      • Contact: Yuhong Chen
    • Nanning, Guangxi, China
      • Not yet recruiting
      • Foresea Life Insurance Guangxi Hospital
      • Contact: Xiaomei Peng
  • Guizhou
    • Guiyang, Guizhou, China
      • Not yet recruiting
      • The Affiliated Cancer Hospital of Guizhou Medical University
      • Contact: Zongyang Liu
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People's Hospital
      • Contact: Hongtao Zhang
  • Hubei
    • Wuhan, Hubei, China
      • Not yet recruiting
      • Tongji Hospital Affiliated to Tongji Medical College Hust
      • Contact: Fan He
  • Hunan
    • Changsha, Hunan, China
      • Not yet recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Hong Wu
    • Changsha, Hunan, China
      • Not yet recruiting
      • Hunan Provincial People's Hospital
      • Contact: Xun Luo
    • Changsha, Hunan, China
      • Not yet recruiting
      • Changsha Jieao Kidney Disease Hospital
      • Contact: Yong Xu
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanchang University
      • Contact: Yan Yan
  • Jilin
    • Changchun, Jilin, China
      • Not yet recruiting
      • The Affiliated Hospital To Changchun University of Chinese Medicine
      • Contact: Mingxin Chang
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Not yet recruiting
      • The First Affiliated Hospital Of Xi'an Jiaotong University
      • Contact: Shifeng Yang
  • Shandong
    • Dezhou, Shandong, China
      • Not yet recruiting
      • Qilu Hospital of Shandong University Dezhou Hospital
      • Contact: Jing Sun
    • Jinan, Shandong, China
      • Not yet recruiting
      • The First Affiliated Hospital of Shandong First Medical University
      • Contact: Zunsong Wang
    • Jinan, Shandong, China
      • Not yet recruiting
      • Central Hospital Affiliated to Shandong First Medical University
      • Contact: Xiaoping Wang
    • Qingdao, Shandong, China
      • Not yet recruiting
      • Qingdao Municipal Hospital
      • Contact: Jian Sun
    • Rizhao, Shandong, China
      • Not yet recruiting
      • People's Hospital of Rizhao
      • Contact: Hong Zhang
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Shanxi Bethune Hospital
      • Contact: Hua Chen
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
      • Contact: Qiang He
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • West China Hospital Sichuan University
      • Contact: Ping Fu
    • Mianyang, Sichuan, China
      • Not yet recruiting
      • Mianyang Central Hospital
      • Contact: Dan Liao
    • Nanchong, Sichuan, China
      • Not yet recruiting
      • Affiliated Hospital of North Sichuan Medical College
      • Contact: Heping Zhang
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Hua Jiang
    • Hangzhou, Zhejiang, China
      • Not yet recruiting
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Contact: Hua Li
    • Jinhua, Zhejiang, China
      • Not yet recruiting
      • Jinhua Hospital of TCM
      • Contact: Yangbiao He
    • Taizhou, Zhejiang, China
      • Not yet recruiting
      • Taizhou Hospital of Zhejiang Province
      • Contact: Liyun Xu
  • Ürümqi
    • Ürümqi, Ürümqi, China
      • Not yet recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Alpati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dissolve AV Peripheral Scoring Drug-coated Balloon; Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter	Device: Dissolve AV Peripheral Scoring Drug-coated Balloon; Subjects in the test group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon; Other Names: Scoring Drug-coated Balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency (TLPP) at 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.	6 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency (TLPP)	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.	12, 24 months post-procedure
Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), so as to confirm the absence of restenosis	Proportion of patients whose peak systolic flow velocity ratio (PSVR) ≤ 2.0, as determined by Doppler ultrasound (DUS), at 6, 12, and 24 months post-procedure, so as to confirm the absence of restenosis.	6, 12, 24 months post-procedure
Clinically-driven Target Lesion Revascularization (CD-TLR)	Any reintervention of a target lesion (including +/-5 mm proximal or distal to the target lesion) as determined by clinical symptoms or dialysis indicators indicating that it is unable to perform dialysis.	1, 6, 12, 18, and 24 months post-procedure
Clinically-driven Target Shunt Revascularization (CD-TSR)		1, 6, 12, 18, and 24 months post-procedure
Device Success	Defined as the ability of the balloon to reach the target lesion, be successfully expanded without rupture, and be successfully withdrawn. Evaluation is based on single balloon dilation catheter.	During the procedure
Technical Success	Defined as residual stenosis of the target lesion post-procedure is ≤ 30%, and no serious adverse events related to the trial device occurred during the perioperative period.	0-5 days post-procedure
Clinical Success	Defined as ability to complete at least one successful hemodialysis session post-procedure.	0-5 days post-procedure

Collaborators and Investigators

• Sponsor: DK Medical Technology (Suzhou) Co., Ltd.
• Investigators: Principal Investigator: Yuzhu Wang, MD, Beijing Haidian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 15, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: drug-coated balloon; hemodialysis; scoring; arteriovenous fistula stenosis
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Constriction, Pathologic; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: VP-P-24-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No