Budd-Chiari SyndromeNCT06960473
A Prospective Study on IVUS and DSA Guidance in the Treatment of Budd-Chiari Syndrome
A study testing Intravascular Ultrasound and Digital Subtraction Angiography in people with Budd-Chiari Syndrome, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Budd-Chiari Syndrome
- What is being tested?
- Intravascular Ultrasound and Digital Subtraction Angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years.
- Primary Budd-Chiari Syndrome (narrowing or occlusion of the inferior vena cava near the hepatic veins or hepatic vein openings).
- Presence of membrane or short segment stenosis or occlusion suitable for balloon dilation (≤ 5 cm).
- Child-Pugh score less than 13.
- The patient or their authorized family member signs an informed consent form, voluntarily participating in the study and agreeing to follow-up.
Who cannot join
- Prior interventional treatment.
- Unfit for balloon dilation or stent placement (e.g., diffuse obstruction of the hepatic veins recommended for TIPS treatment, end-stage liver disease recommended for liver transplantation, etc.).
- Coexisting severe heart disease (such as heart failure, severe arrhythmias), liver or kidney failure, severe infections, iodinated contrast agent allergy.
- Coexisting hepatocellular carcinoma or other malignant tumors.
- Pregnant or breastfeeding women.
- Patients with a life expectancy of less than 1 year.
- Patients unable to complete follow-up or cooperate with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Interventional Radiology, the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
About this study
Official title: A Prospective Randomized Controlled Clinical Study on Interventional Treatment of Budd-Chiari Syndrome Guided by IVUS and DSA
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.
Read the detailed description
This study aims to establish a precise interventional diagnostic and therapeutic system for Budd-Chiari Syndrome (BCS) based on IVUS assistance by comparing it with conventional DSA-guided diagnosis and intervention. The goal is to improve diagnostic accuracy and treatment outcomes for complex and difficult BCS patients using IVUS technology, reduce the incidence of postoperative restenosis, and enhance long-term patient prognosis. Specific objectives include:
- Enhance the diagnostic accuracy for BCS patients, particularly in determining the nature of vascular obstruction and assessing hemodynamic status.
- Optimize the interventional treatment strategy for BCS, including the selection and implantation of balloons and stents, and reduce surgical complications.
- Increase the patency rate of vessels after interventional treatment and lower the incidence of restenosis.
- Establish a set of IVUS-based precise diagnosis and treatment processes for BCS, promoting the application and dissemination of IVUS technology in BCS diagnosis and treatment.
- Conditions
- Budd-Chiari Syndrome
- Being tested
- Intravascular Ultrasound, Digital Subtraction Angiography
- Medical subject headings
- Budd-Chiari Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular UltrasoundDevice
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.
Digital Subtraction AngiographyDevice
The DSA group patients will have the appropriate balloon dilation selected for the occluded segment based on the DSA measurement results.
| Study group | Role | What they receive |
|---|---|---|
| IVUS Group | Experimental | Patients receiving intervention guided by Intravascular Ultrasound (IVUS). Receives: Device: Intravascular Ultrasound |
| DSA Group | Active comparator | Patients receiving intervention guided by Digital Subtraction Angiography (DSA). Receives: Device: Digital Subtraction Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Restenosis
At the 1 month, 3 months, 6 months, and 12 months follow-up after surgery, vascular patency will be assessed through imaging examinations such as ultrasound, CT, or MRI, and the incidence of restenosis will be recorded to compare the treatment outcomes between the IVUS group and the DSA group
Measured: Follow-up and assessment will be conducted at 1 month, 3 months, 6 months, and 12 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start18 May 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Budd-Chiari SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960473
- Sponsor's protocol ID
- XYFY2024-JS004-01
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Study on Interventional Treatment of Budd-Chiari Syndrome Guided by IVUS and DSA
- ClinicalTrials.gov ID
- NCT06960473
- Acronym / sponsor ID
- XYFY2024-JS004-01
- Conditions
- Budd-Chiari Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 18 May 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to establish a precise interventional diagnostic and therapeutic system for Budd-Chiari Syndrome (BCS) based on IVUS assistance by comparing it with conventional DSA-guided diagnosis and intervention. The goal is to improve diagnostic accuracy and treatment outcomes for complex and difficult BCS patients using IVUS technology, reduce the incidence of postoperative restenosis, and enhance long-term patient prognosis. Specific objectives include:
- Enhance the diagnostic accuracy for BCS patients, particularly in determining the nature of vascular obstruction and assessing hemodynamic status.
- Optimize the interventional treatment strategy for BCS, including the selection and implantation of balloons and stents, and reduce surgical complications.
- Increase the patency rate of vessels after interventional treatment and lower the incidence of restenosis.
- Establish a set of IVUS-based precise diagnosis and treatment processes for BCS, promoting the application and dissemination of IVUS technology in BCS diagnosis and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IVUS Group | Experimental | Device: Intravascular UltrasoundPatients receiving intervention guided by Intravascular Ultrasound (IVUS). |
| DSA Group | Active comparator | Device: Digital Subtraction AngiographyPatients receiving intervention guided by Digital Subtraction Angiography (DSA). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 75 years.
- Primary Budd-Chiari Syndrome (narrowing or occlusion of the inferior vena cava near the hepatic veins or hepatic vein openings).
- Presence of membrane or short segment stenosis or occlusion suitable for balloon dilation (≤ 5 cm).
- Child-Pugh score less than 13.
- The patient or their authorized family member signs an informed consent form, voluntarily participating in the study and agreeing to follow-up.
Key exclusion criteria (7 listed)
- Prior interventional treatment.
- Unfit for balloon dilation or stent placement (e.g., diffuse obstruction of the hepatic veins recommended for TIPS treatment, end-stage liver disease recommended for liver transplantation, etc.).
- Coexisting severe heart disease (such as heart failure, severe arrhythmias), liver or kidney failure, severe infections, iodinated contrast agent allergy.
- Coexisting hepatocellular carcinoma or other malignant tumors.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular UltrasoundIn 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 | IVUS Group |
| Digital Subtraction AngiographyThe DSA group patients will have the appropriate balloon dilation selected for the occluded segment based on the DSA measurement results. | Device | DSA Group |
Primary outcome
Rate of Restenosis
Time frame: Follow-up and assessment will be conducted at 1 month, 3 months, 6 months, and 12 months post-surgery.
At the 1 month, 3 months, 6 months, and 12 months follow-up after surgery, vascular patency will be assessed through imaging examinations such as ultrasound, CT, or MRI, and the incidence of restenosis will be recorded to compare the treatment outcomes between the IVUS group and the DSA group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Related trials for Budd-Chiari Syndrome
RecruitingObservational study
Freiburg TIPS Registry
Liver Cirrhosis, Portal Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular Ultrasound and Digital Subtraction Angiography in people with Budd-Chiari Syndrome, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Restenosis (time frame: Follow-up and assessment will be conducted at 1 month, 3 months, 6 months, and 12 months post-surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.