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

NCT06503692 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-01-09

No results posted yet for this study

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.

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.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Pei Wang, MD · The First Affiliated Hospital of Zhengzhou University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06503692 on ClinicalTrials.gov