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

NARecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

August 13, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Arteriovenous Graft Stenosis
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.

Trial Locations (7)

Unknown

NOT_YET_RECRUITING

Beijing Tongren Hospital Affiliated to Capital Medical University, Beijing

NOT_YET_RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

NOT_YET_RECRUITING

South China Hospital of Shenzhen University, Shenzhen

NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

NOT_YET_RECRUITING

The Second Affiliated Hospital of Nanjing Medical University, Nanjing

RECRUITING

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai

NOT_YET_RECRUITING

National University Hospital of Singapore, Singapore

All Listed Sponsors
lead

DK Medical Technology (Suzhou) Co., Ltd.

INDUSTRY