A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of Budd-Chiari Syndrome

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035479

Enrollment

Unknown

Registered

2020-08-12

Start date

2020-12-01

Completion date

Unknown

Last updated

2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Budd-Chiari Syndrome

Interventions

experimental group:drug-coated balloon

control group:balloon

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years old; 2. Imaging confirmed obstruction of hepatic vein or / and inferior vena cava (stenosis or occlusion); 3. Patients and their family members agreed to join the clinical trial and signed; 4. Patients with stenosis or occlusion without previous treatment or balloon dilatation.

Exclusion criteria

Exclusion criteria: 1. Surgical intervention was performed before; 2. Abnormal coagulation function can not be corrected; 3. Stents were implanted before the lesion; 4. Patients with upper gastrointestinal bleeding and unstable vital signs due to posthepatic portal hypertension; 5. Combined with active infection; 6. Severe contrast medium allergy; 7. Women are pregnant or lactating.

Design outcomes

Primary

Measure	Time frame
Patency rate at 3 months;Patency rate at 6 months;	—

Secondary

Measure	Time frame
Correlation between API technology and pressure;	—

Countries

China

Contacts

Public ContactJocee Zhang

Fudan University Zhongshan Hospital

zhang.wen2@zs-hospital.sh.cn+86 13774267409

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026