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

NCT06320912 | Not Yet Recruiting

• 1 other identifier: TIPS01
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension

Keywords

Portal hypertension

Outcome Measures

Primary Outcomes (1)

• Postoperative Stent Patency Rate

  In the absence of a secondary intervention, portal venography indicates a luminal narrowing of ≤50% and a portal pressure gradient (PPG) of ≤12mmHg or a reduction of ≥50% from the baseline value prior to the surgery.

  12 months

Secondary Outcomes (9)

• Immediate Postoperative Technical Success Rate

  Immediate postoperative

• Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively

  1 Month, 6 Months, and 12 Months

• Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively

  1 Month, 6 Months, and 12 Months

• Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively

  1 Month, 6 Months, and 12 Months

• All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively

  1 Month, 6 Months, and 12 Months

Study Arms (2)

Group(A)

EXPERIMENTAL

Device: The intraparenchymal portal vein covered stent

Group(B)

ACTIVE COMPARATOR

Device: TIPS Covered Stent System GORE

Interventions

The intraparenchymal portal vein covered stent DEVICE

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(A)

TIPS Covered Stent System GORE DEVICE

The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.

Group(B)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

chaojun gu

CONTACT

+86-13636491192; chaojun.gu@sqmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: April 5, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)