Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320912
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-03-13
Brief Title:
Efficacy and Safety of Intraparenchymal Portal Vein Covered Stents in Treating Portal Hypertension and Its Complications
Sponsor:
Shanghai Shenqi Medical Technology Co Ltd
Organization:
Shanghai Shenqi Medical Technology Co Ltd
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None