Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT06117735
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of PTFE Covered Stent for Treating Portal Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006975', 'term': 'Hypertension, Portal'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019168', 'term': 'Portasystemic Shunt, Transjugular Intrahepatic'}], 'ancestors': [{'id': 'D011170', 'term': 'Portasystemic Shunt, Surgical'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 177}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2023-10-31', 'studyFirstSubmitQcDate': '2023-10-31', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Secondary patency rate', 'timeFrame': '1 year', 'description': 'Second patency was defined as graft stenosis or occlusion with patency restored and maintained by TIPS revision.'}, {'measure': 'all cause mortalidy', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Device-related adverse events', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Serious adver events', 'timeFrame': 'through study completion, an average of 1 year'}], 'primaryOutcomes': [{'measure': 'Primary shunt patency rate', 'timeFrame': '1 year', 'description': 'shunt dysfunction was defined as a TIPS stenosis \\>=50% or complete occlusion. Primary patency referred to continuous unassisted patency of the shunt.'}], 'secondaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': 'immediately after procedure', 'description': 'Successful implantation of a PTFE covered stent to create an intrahepatic portosystemic shunt and successful retrieval of the delivery system.'}, {'measure': 'Procedure success rate', 'timeFrame': 'immediately after procedure', 'description': 'PPG (portosystemic pressure gradient) reduces more than 20% or PPG \\<=12mmHg'}, {'measure': 'Treatment success rate', 'timeFrame': 'during the perioperative period', 'description': 'Treatment success is defined as the success of the procedure without major adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transjugular intrahepatic portosystemic shunt'], 'conditions': ['Portal Hypertension']}, 'descriptionModule': {'briefSummary': 'To validate the safety and efficacy of TIPS (Transjugular Intrahepatic Portosystemic Shunt) using PTFE covered stent in the treatment of portal hypertension.', 'detailedDescription': 'This trial is a prospective multi-center single-arm confirmatory study. A total 177 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo TIPS using the PTFE covered stent for the treatment of portal hypertension. Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days and 360 days postoperatively. Secondary endpoint measures include surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverce events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the PTFE covered stent produced by Enlight Medical Technologies (Shanghai) Co., Ltd..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for this study:\n\n* Age 18-85 years;\n* Cirrhotic portal hypertension required for TIPS;\n* Willingness to comply with the protocol requirements and ata collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria are not eligible for this study:\n\n* Concomitant chronic heart or lung disease;\n* Presence or suspicion of active systemic, hepatobiliary or ascitic fluid infection;\n* Severe hepatic failure (with bilirubin levels of \\>51.3μmol/L or Child-Pugh \\>13 or MELD \\>18);\n* Hepatic encephalopathy;\n* Coagulation disorders;\n* Portal vein thrombosis;\n* Allergies to device components;\n* Extrahepatic malignancy;\n* Pregnant or brestfeeding women or those planning pregnancy during the trial peroid;\n* Intending or currently participating in another interventional clinical trial;\n* Other conditions deemed inappropriate for participation in this study by the investigator.'}, 'identificationModule': {'nctId': 'NCT06117735', 'briefTitle': 'Clinical Study of PTFE Covered Stent for Treating Portal Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enlight Medical Technologies (Shanghai) Co., Ltd'}, 'officialTitle': 'A Prospective, Multicenter, Single-arm Clinical Study of PTFE Covered Stent for Treating Portal Hypertension.', 'orgStudyIdInfo': {'id': 'YM-2023-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PTFE covered stent', 'description': 'Use the experimental device, PTFE covered stent to treat protal hypertension.', 'interventionNames': ['Device: Transjugular Intrahepatic Portosystemic shunt']}], 'interventions': [{'name': 'Transjugular Intrahepatic Portosystemic shunt', 'type': 'DEVICE', 'description': 'The experimental device is a class III implanted shunt device, which will be used to create a shunt between intrahepatic and portosystemic to reduce portal hypertension.', 'armGroupLabels': ['PTFE covered stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhuting Fang, MD', 'role': 'CONTACT'}], 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Xiong, MD', 'role': 'CONTACT'}], 'facility': 'The first affiliated hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shanghai', 'state': 'Jinshan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yuan, MD', 'role': 'CONTACT'}], 'facility': 'Shanghai Public Health Clinical Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Duiping Feng, MD', 'role': 'CONTACT'}, {'name': 'Duiping Feng, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Echo Hu', 'role': 'CONTACT', 'email': 'echo_hu@enlight-medical.com', 'phone': '08615221991087'}], 'overallOfficials': [{'name': 'Bin Xiong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enlight Medical Technologies (Shanghai) Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}