Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Shenqi Medical Technology Co., Ltd

About this trial

The objective of this study is to assess the non-inferiority of the intraparenchymal portal vein covered stent in terms of safety and efficacy for managing portal hypertension and its related complications, in comparison to the currently available TIPS Covered Stent System by GORE.

Eligibility criteria

Qualifiers

Age 18-75 years (inclusive); male or non-pregnant female.

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.

Disqualifiers

Severe right heart failure, congestive heart failure (LVEF < 40%), or severe valvular heart dysfunction.

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).

Trial design

Treatments tested in this trial

  • The intraparenchymal portal vein covered stent
  • TIPS Covered Stent System GORE

Treatment groups

258 Participants
are divided into 2 treatment groups