Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications
NCT ID: NCT06320912
Last Updated: 2024-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
258 participants
INTERVENTIONAL
2024-04-05
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group(A)
The intraparenchymal portal vein covered stent
The intraparenchymal portal vein covered stent, produced by Shanghai Shenqi Medical Technology Co., Ltd., is used for a transjugular approach. It establishes an artificial shunt between the hepatic vein and the main branches of the portal vein within the liver. This helps in reducing portal venous pressure and alleviating or improving the symptoms of portal hypertension and its complications, such as variceal bleeding, gastropathy, refractory ascites, and/or hepatic hydrothorax.
Group(B)
TIPS Covered Stent System GORE
The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.
Interventions
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The intraparenchymal portal vein covered stent
The intraparenchymal portal vein covered stent, produced by Shanghai Shenqi Medical Technology Co., Ltd., is used for a transjugular approach. It establishes an artificial shunt between the hepatic vein and the main branches of the portal vein within the liver. This helps in reducing portal venous pressure and alleviating or improving the symptoms of portal hypertension and its complications, such as variceal bleeding, gastropathy, refractory ascites, and/or hepatic hydrothorax.
TIPS Covered Stent System GORE
The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with cirrhosis and associated complications of portal hypertension (such as esophageal and gastric variceal bleeding, refractory ascites), and meeting the consensus recommendations for TIPS indications (see Appendix 5).
* Participants must understand the purpose of the trial, voluntarily participate, sign an informed consent form, and be willing to complete the follow-up according to the project requirements.
Exclusion Criteria
* Uncontrolled systemic infection or inflammation.
* Persistent moderate to severe pulmonary hypertension after treatment (tricuspid regurgitant peak velocity \> 3.4 m/s or pulmonary artery systolic pressure \> 50 mmHg).
* Patients in hepatic encephalopathy coma or comatose phase (West Haven Criteria Stage III, IV).
* Severe liver dysfunction, Child-Pugh score \> 13, or MELD score \> 18.
* Serum creatinine (Scr) \> 178 umol/L or on dialysis.
* Stage IIIa or higher liver malignancy.
* Budd-Chiari syndrome, hepatic veno-occlusive disease, or obstructive cholestasis.
* Polycystic liver disease.
* Unrectifiable coagulopathy (INR \> 5 or PLT count \< 20 x 10\^9/L).
* Main portal vein thrombosis occupying \> 50% of the lumen area or cavernous transformation of the portal vein.
* Previous TIPS procedure or planned liver transplantation within a year.
* Allergy to contrast agents or nickel-titanium alloys.
* Life expectancy less than 1 year.
* Participation in other drug or medical device clinical trials within three months before screening.
* Other conditions deemed by the researcher as unsuitable for participation in this clinical trial.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Shenqi Medical Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jianbo Zhao
Role: primary
Other Identifiers
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TIPS01
Identifier Type: -
Identifier Source: org_study_id
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