Clinical trial NCT06320912: Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications
Official title: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Clinical Study Evaluating the Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents for the Treatment of Portal Hypertension and Its Complications
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Portal Hypertension
Keywords: Portal hypertension
Lead sponsor: Shanghai Shenqi Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This study is a prospective, multicenter, randomized controlled, non-inferiority clinical trial. It plans to enroll approximately 258 qualified participants from about 25 research centers nationwide. Participants will be randomly assigned in a 1:1 ratio to either the experimental group or the control group for the treatment of portal hypertension and its related complications. The primary endpoint of the study is the patency rate of the stents 12 months after the initial surgery. All participants will undergo clinical follow-ups at 1 month, 6 months, and 1 year post-stent implantation.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
measure: Postoperative Stent Patency Rate
timeFrame: 12 months
Secondary outcomes:
measure: Immediate Postoperative Technical Success Rate
timeFrame: Immediate postoperative
measure: Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively
timeFrame: 1 Month, 6 Months, and 12 Months
measure: Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively
timeFrame: 1 Month, 6 Months, and 12 Months
measure: Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively
timeFrame: 1 Month, 6 Months, and 12 Months
measure: All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively
timeFrame: 1 Month, 6 Months, and 12 Months
measure: Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively
timeFrame: 1 Month, 6 Months, and 12 Months
measure: Incidence of Portal Hypertension Rebleeding Confirmed by Endoscopy or Clinical Investigator at 1 Month, 6 Months, and 12 Months Postoperatively (For Original Bleeding Subjects Only)
timeFrame: 1 Month, 6 Months, and 12 Months
measure: Incidence of Ultrasound-Confirmed Recurrence of Grade 2 or Higher Ascites due to Portal Hypertension at 1 Month, 6 Months, and 12 Months Postoperatively (For Subjects with Original Ascites Only)
timeFrame: 1 Month, 6 Months, and 12 Months
measure: Incidence of Adverse Events/Serious Adverse Events
timeFrame: 12 Months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
Study officials:
References: