Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorC. R. Bard
About this trial
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. The primary evaluation endpoint of this Study is the stent patency at 6 months after treatment completion .
Eligibility criteria
Qualifiers
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;
Disqualifiers
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 interventional treatment (such as TIPS, surgical shunt and retrograde transvenous obliteration (-RTO) for treatment of complications from portal hypertension. Note: The subject who have received -RTO for variceal bleeding at least 8 weeks before signing the informed consent form can be included in the clinical trial;
The subject who needs to receive or have received splenectomy;
Trial design
Treatments tested in this trial
- TIPS Stent Graft
Treatment groups
166 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov