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NOT YET RECRUITING
NCT06960473
NA

A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome

Sponsor: The Affiliated Hospital of Xuzhou Medical University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the effectiveness of interventional treatment guided by Intravascular Ultrasound (IVUS) compared to Digital Subtraction Angiography (DSA) in patients with Budd-Chiari Syndrome (BCS). Using a prospective, randomized controlled trial design, patients who meet the diagnostic criteria for BCS and are suitable for interventional treatment are randomly divided into the IVUS group and the DSA group. The IVUS group will undergo detailed assessment of vascular structure before interventional treatment to select the appropriate balloon for dilation, whereas the control group will make decisions based on DSA results. The primary endpoint of the study is the postoperative restenosis rate, while secondary endpoints include complications of interventional treatment, liver function, and patient survival rate. Successful implementation of this study will provide new technical means to optimize interventional treatment strategies for BCS, and help improve treatment outcomes and long-term prognosis for patients.

Official title: A Prospective Randomized Controlled Clinical Study on Interventional Treatment of Budd-Chiari Syndrome Guided by IVUS and DSA

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2025-05-18

Completion Date

2026-12-31

Last Updated

2025-05-07

Healthy Volunteers

No

Interventions

DEVICE

Intravascular Ultrasound

In the IVUS group, the diameter of the reference vessel (the normal segment of the artery distal to the occlusion) is measured using Intravascular Ultrasound (IVUS). Based on the IVUS measurements, an appropriate balloon is selected to dilate the occluded segment.

DEVICE

Digital Subtraction Angiography

The DSA group patients will have the appropriate balloon dilation selected for the occluded segment based on the DSA measurement results.

Locations (1)

Department of Interventional Radiology, the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China