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

NCT06960473 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-05-07

No results posted yet for this study

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.

Conditions

  • Budd-Chiari Syndrome

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-05-18
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

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 NCT06960473 on ClinicalTrials.gov