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RECRUITING
NCT06503692
NA

Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

Sponsor: DK Medical Technology (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, randomized controlled clinical study. Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure balloon in treating such lesions, so as to provide a basis for optimizing the treatment of such lesions. This study will be conducted in seven (7) clinical trial institutions, with a total of 140 subjects included. After randomization, the subjects will use either the scoring balloon dilatation catheter, developed and produced by DK Medical Technology Co., Ltd., or the peripheral balloon dilatation catheter for surgical treatment. Clinical follow-up will be carried out within 5 days, 3 months, 6 months, and 12 months after the procedure.

Official title: A Multicentre, Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2024-08-13

Completion Date

2026-12

Last Updated

2025-01-09

Healthy Volunteers

No

Interventions

DEVICE

DKutting PTA Scoring Balloon Dilatation Catheter

The device consists of a balloon catheter with scoring elements (triangular cross-section) fixed to the surface of the balloon and distributed radially at every 120°. When the balloon is inflated, the expansion force is focused along the scoring elements, causing it to expand under lower balloon pressure.

DEVICE

Peripheral Balloon Catheter

The device is an over-the-wire (OTW) double-lumen balloon catheter. The balloon is inflated to a known diameter at a specified pressure.

Locations (7)

Beijing Tongren Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

South China Hospital of Shenzhen University

Shenzhen, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

National University Hospital of Singapore

Singapore, Singapore