[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622955":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":10,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":33,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":10,"enrollmentInfo":37,"targetDuration":40,"studyType":41,"phases":10,"briefSummary":42,"conditions":43,"keywords":47,"overallStatus":53,"whyStopped":10,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":10},{"fullName":5,"class":6},"W.L.Gore & Associates","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects treated for portal hypertension with the Registry device",null,"The study population consists of patients treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for portal hypertension and its complications including but not limited to variceal bleeding and\u002For ascites.",[13],"Device: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)","The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) was developed and approved for the treatment of portal hypertension and its complications such as bleeding from enlarged or swollen veins (variceal bleeding) and abnormal build-up of fluid in the abdomen that does not respond to therapy (ascites which recurs despite conventional treatment).\n\nThe Registry Device is a small tube (stent) that creates a pathway for blood flow. It consists of a metal frame (nitinol), covered with a thin, flexible material called expandable polytetrafluoroethylene (ePTFE).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"The VIATIPS clinical study team","CONTACT","800-437-8181","viatips@wlgore.com",{"type":27,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100622955","viatorr-tips-study-evaluating-6-10mm-diameters-viatips-100622955",false,"NCT07390344","VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)","VIATIPS","Inclusion Criteria:\n\n1. The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.\n2. The subject has cirrhotic portal hypertension.\n3. The subject is ≥18 years of age.\n4. The subject is capable of complying with protocol requirements, including follow up.\n5. The subject or legal representative signed the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.\n2. The subject has received a liver transplantation. Patients on the transplant list are still eligible.\n3. The subject has a life expectancy of less than 6 months.\n4. The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and\u002For carcinoma in situ of the cervix remain eligible.\n5. The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \\> 25 or Child Pugh Score of \\> 14.\n6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.\n7. The subject is pregnant at the time of informed consent signature.\n8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.","ALL","18 Years",{"count":38,"type":39},152,"ESTIMATED","2 Years","OBSERVATIONAL","This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.\n\nAdditionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.",[44,45,46],"Ascites","Variceal Bleeding","Portal Hypertension Related to Cirrhosis",[48,49,50,51,52],"portal hypertension","TIPS","cirrhosis","decompensated","Transjugular Intrahepatic Portosystemic Shunt","NOT_YET_RECRUITING","2026-02-05",{"date":56,"type":57},"2026-02-10","ACTUAL",{"date":59,"type":39},"2026-06",{"date":61,"type":39},"2029-09-30",{"name":5,"class":6}]