Portal HypertensionNCT06320912
Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications
A study testing The intraparenchymal portal vein covered stent and TIPS Covered Stent System GORE in people with Portal Hypertension, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- The intraparenchymal portal vein covered stent and TIPS Covered Stent System GORE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 5 Apr 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong
Jianbo Zhao
About this study
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
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.
Read the 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.
- Conditions
- Portal Hypertension
- Being tested
- The intraparenchymal portal vein covered stent, TIPS Covered Stent System GORE
- Keywords
- Portal hypertension
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intraparenchymal portal vein covered stentDevice
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.
TIPS Covered Stent System GOREDevice
The GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter.
| Study group | Role | What they receive |
|---|---|---|
| Group(A) | Experimental | Not described Receives: Device: The intraparenchymal portal vein covered stent |
| Group(B) | Active comparator | Not described Receives: Device: TIPS Covered Stent System GORE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (9)
Immediate Postoperative Technical Success Rate
Successful insertion and smooth withdrawal of the covered stent and delivery system, successful establishment of a shunt, accurate positioning of the stent, and postoperative angiography showing ≤30% diameter narrowing.
Measured: Immediate postoperative
Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively
Measured: 1 Month, 6 Months, and 12 Months
Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively
Measured: 1 Month, 6 Months, and 12 Months
Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively
Measured: 1 Month, 6 Months, and 12 Months
All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively
Measured: 1 Month, 6 Months, and 12 Months
Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively
Measured: 1 Month, 6 Months, and 12 Months
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)
Measured: 1 Month, 6 Months, and 12 Months
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)
Measured: 1 Month, 6 Months, and 12 Months
Incidence of Adverse Events/Serious Adverse Events
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start5 Apr 2024 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320912
- Sponsor's protocol ID
- TIPS01
- Status last verified
- Jan 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06320912
- Acronym / sponsor ID
- TIPS01
- Conditions
- Portal Hypertension
- Keywords
- Portal hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group(A) | Experimental | Device: The intraparenchymal portal vein covered stent |
| Group(B) | Active comparator | Device: TIPS Covered Stent System GORE |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intraparenchymal portal vein covered stentThe 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. | Device | Group(A) |
| TIPS Covered Stent System GOREThe GORE® VIATORR® Transjugular Intrahepatic Portosystemic Shunt (TIPS) Covered Stent consists of an implantable covered stent and a percutaneous delivery catheter. | Device | Group(B) |
Primary outcome
Postoperative Stent Patency Rate
Time frame: 12 months
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.
9 secondary outcomes
Immediate Postoperative Technical Success Rate
Time frame: Immediate postoperative
Incidence of Secondary Interventions at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Stent Dysfunction at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Major Adverse Events (MAE) at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
All-Cause Mortality Rates at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Grade II or Higher Hepatic Encephalopathy at 1 Month, 6 Months, and 12 Months Postoperatively
Time frame: 1 Month, 6 Months, and 12 Months
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)
Time frame: 1 Month, 6 Months, and 12 Months
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)
Time frame: 1 Month, 6 Months, and 12 Months
Incidence of Adverse Events/Serious Adverse Events
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intraparenchymal portal vein covered stent and TIPS Covered Stent System GORE in people with Portal Hypertension, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chaojun gu (+86-13636491192, chaojun.gu@sqmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Stent Patency Rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.