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

NCT06422845 | Recruiting

• 1 other identifier: VP-P-24-012
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 33

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.

Conditions

Arteriovenous Fistula Stenosis

Keywords

arteriovenous fistula stenosis; scoring; hemodialysis; drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Target Lesion Primary Patency (TLPP)

  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

  6, 12, 24 months post-procedure

• Clinically-driven Target Lesion Revascularization (CD-TLR)

  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

  During the procedure

Study Arms (1)

Dissolve AV Peripheral Scoring Drug-coated Balloon

EXPERIMENTAL

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

Device: Dissolve AV Peripheral Scoring Drug-coated Balloon

Interventions

Dissolve AV Peripheral Scoring Drug-coated Balloon DEVICE

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

Also known as: Scoring Drug-coated Balloon

Dissolve AV Peripheral Scoring Drug-coated Balloon

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and ≤ 80 years old;
• The patient's AVF/AVG is mature and has successfully completed hemodialysis at least once;
• The target lesion is located at the AVF/AVG return vein and venous side anastomosis;
• 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.;
• 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);
• 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;
• The patient voluntarily signs the informed consent form.

You may not qualify if:

• Women of childbearing age whose preoperative pregnancy test is not negative, and women who are breastfeeding;
• Calcified lesions that are not expected to be expandable with balloons;
• Patients with thrombosis at the access stenosis site;
• The target lesion is located at the blood supply artery and arterial anastomosis;
• Patients known to be allergic to or intolerant to contrast media and paclitaxel;
• The patient's life expectancy is less than 2 years;
• Patients with systemic lupus erythematosus and antineutrophil cytoplasmic antibody (ANCA)-associated small vessel vasculitis;
• Patients with kidney transplantation or those who planned to undergo kidney transplantation or switch to peritoneal dialysis;
• Vascular access infection or systemic active infection;
• Those who have participated in unfinished clinical trials of other drugs or devices;
• Patients with other medical conditions that the investigator believes are not suitable to participate in this study.

Sponsors & Collaborators

• DK Medical Technology (Suzhou) Co., Ltd.: lead

Study Sites (33)

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

Liuchow, 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 Officials

• Yuzhu Wang, MD

  Beijing Haidian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuzhu Wang, MD

CONTACT

18701387950; wyz4417@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (33)