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

Not Applicable

Recruiting

• Conditions: Arteriovenous Fistula Stenosis
• Interventions: Device: Dissolve AV Peripheral Scoring Drug-coated Balloon

• Registration Number: NCT06422845
• Lead Sponsor: DK Medical Technology (Suzhou) Co., Ltd.

Brief 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.

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 Timeline

• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Study Start: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 328

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dissolve AV Peripheral Scoring Drug-coated Balloon	Dissolve AV Peripheral Scoring Drug-coated Balloon	Subjects in this group are treated with Dissolve AV Peripheral Scoring Drug-coated Balloon dilatation catheter

Primary Outcome Measures

Name	Time	Method
Target Lesion Primary Patency (TLPP) at 6 months post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Clinically-driven Target Lesion Revascularization (CD-TLR)	1, 6, 12, 18, and 24 months post-procedure	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.
Device Success	During the procedure	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.
Technical Success	0-5 days post-procedure	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.
Clinical Success	0-5 days post-procedure	Defined as ability to complete at least one successful hemodialysis session post-procedure.
Target Lesion Primary Patency (TLPP)	12, 24 months post-procedure	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.
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	6, 12, 24 months post-procedure	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.
Clinically-driven Target Shunt Revascularization (CD-TSR)	1, 6, 12, 18, and 24 months post-procedure

Trial Locations

Locations (33)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Haidian Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, 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; 🇨🇳 Liuzhou, 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