Recruiting NA Portal Hypertension Related to Cirrhosis

Tests treatment safety and results for Portal Hypertension Related to Cirrhosis

Official title Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension

ClinicalTrials.gov ID: NCT06669806

What this study is testing

What it's testing
This Study is a prospective, multi-center, single-arm objective perform an criteria (OPC) study. A 12 months follow-up study on the patients who intend to receive the treatment of cirrhosis and complications of portal hypertension with the TIPS Stent Graft will be conducted.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 75

You may be able to join if

  • The subject who is 18 years old or above but 75 years old or below;
  • The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding...
  • The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
  • The subject with platelet count≥ 20×10\^9 /L;
  • people or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and...

You likely can't join if

  • The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
  • According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and...
  • The subject who has received surgical or treatment treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for...
  • The subject who needs to receive or have received splenectomy;
  • The subject who has received or plan to receive liver transplantation;
  • The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the...
See the full eligibility criteria
Who can join
  • The subject who is 18 years old or above but 75 years old or below;
  • The subject who is diagnosed with portal hypertension caused by liver cirrhosis with the history of gastrointestinal variceal bleeding or bleeding, hepatic hydrothorax, and refractory or recurrent ascites;
  • The subject must have adequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of ≤13 or Child-Pugh Score of ≤18;
  • The subject with platelet count≥ 20×10\^9 /L;
  • people or their guardians who can understand the content of the clinical trial, voluntarily participate in the clinical trial and sign the ICF and can complete the follow-up period according to the requirements of the...
What rules you out
  • The subject who is pregnant or lactating or plan to get pregnant during the clinical trial;
  • According to the judgment of investigator, the subject with main portal vein thrombosis which thrombus occupying \>50% of the portal vein lumen and affecting postoperative hemodynamics;
  • The subject who has received surgical or treatment treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who...
  • The subject who needs to receive or have received splenectomy;
  • The subject who has received or plan to receive liver transplantation;
  • The subject who cannot have a shunt channel established in the liver parenchyma between the hepatic vein and the portal vein as determined by the investigators;
  • The subject with extrahepatic or hepatic malignancies;
  • The subject with Budd-Chiari syndrome and hepatic sinusoidal obstruction syndrome;
  • The subject with congenital cystic dilatation of bile duct (Caroli disease) and obstructive dilation of biliary tract;
  • The subject with polycystic liver disease;
  • The subject with cavernous transformation of the portal vein;
  • The subject with severe or refractory hepatic encephalopathy (Grade 2 or above according to the West Haven Criteria);
  • The subject with a TBIL level higher than 51.3 μmol/L (excluding the Patients with cholestatic cirrhosis);
  • The subject with coagulation disorders (INR: \>2.5);
  • The subject with a systolic pressure lower than 80 mmHg;
  • The subject with severe tricuspid regurgitation or congestive heart failure;
  • The subject with myocardial infarction within the past 3 months;
  • The subject with moderate to severe pulmonary arterial hypertension, or severe hepatopulmonary syndrome;
  • The subject with uncontrolled systemic infection or inflammation;
  • The subject with severe renal insufficiency (Scr level:\>199.5 μmol/L) or needing to receive dialysis;
  • The subject known to be allergic to the contrast media or to the constituent materials of the TIPS covered segment;
  • The subject with the history of epilepsy or mental illness or with cognitive impairment;
  • The subject with the expected survival time of less than 1 year;
  • The subject who is otherwise determined as ineligible for participation in this Study by investigators;
  • The subject who is participating in any other unfinished drug or medical device clinical trials.

The study team makes the final eligibility decision.

Where it's taking place

  • Changsha, Hunan, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.