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Peripheral Scoring Drug-coated Balloon in the Treatment of Hemodialysis Arteriovenous Fistula Stenosis | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT06422845•DK Medical Technology (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

Locations (33)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Haidian Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 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

Liuchow, Guangxi, China

Foresea Life Insurance Guangxi Hospital

Nanning, Guangxi, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Key Dates

Start Date

September 30, 2024

Primary Completion Date

July 1, 2027

Completion Date

July 1, 2027

Last Updated

January 9, 2025

Enrollment

328

ESTIMATED participants

Conditions

Arteriovenous Fistula Stenosis

Interventions

Dissolve AV Peripheral Scoring Drug-coated Balloon

DEVICE

Contacts

Yuzhu Wang, MD

CONTACT

18701387950 wyz4417@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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