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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.
Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.
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).
Subjects will receive the Registry Device as part of standard treatment for their condition. This means within this Registry, the information collected reflects the use of the Registry Device in typical, everyday medical practice by physicians, often referred to as "real world" data.
Patient total sample size will target a total approximately 152 patients treated with GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm).
Subjects who meet all criteria may be enrolled in the Registry.
The first visit after the procedure will be performed at the day of discharge or within 7 days after the procedure, whatever comes first. Subjects will have follow-up visits at 1 month, 3 months, 6 months, 12 months, and 24 months after their procedure so their health and the performance of the Registry Device can be monitored.
During follow-up visits, the doctor will perform a physical exam, review medications, and perform a condition status assessment. Imaging will not be collected as part of the Registry but may be ordered by the doctor for safety follow-up purposes as imaging is often collected as part of standard medical care.
Subjects will be asked to complete Quality of Life questionnaires at each follow-up visit to collect information on their well-being and daily life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated for portal hypertension with the Registry device | 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/or ascites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) | Device | 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). The 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects achieving primary patency through 2 years | Freedom from shunt occlusion on imaging or from reintervention due to shunt dysfunction (occlusion or thrombosis on imaging or significant stenosis confirmed by venography). | Shunt primary patency will be analyzed at 1, 3, 6, 12 and 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subject procedures that are a technical success | Successful delivery and deployment of the device to create an intrahepatic shunt connection between the portal and hepatic circulations. | Day 0 |
| Reduction in portosystemic gradient (PSG) |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects 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/or ascites.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| The VIATIPS clinical study team | Contact | 800-437-8181 | viatips@wlgore.com |
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| ID | Term |
|---|---|
| D001201 | Ascites |
| D006975 | Hypertension, Portal |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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|
Difference between the pre-TIPS gradient (prior to TIPS device deployment) and the post-TIPS gradient (at completion of procedure).
| Day 0 |
| Proportion of Subjects with variceal rebleeding through 2 years | Variceal rebleeding is defined as any endoscopically proven variceal bleeding event that occurs post procedure. The inability to control acute bleeding after device implant at time of procedure will count as a rebleeding event on day 0. | Variceal rebleeding will be analyzed at 1, 3, 6, 12 and 24 months. |
| Rate of large volume paracentesis (LVP) through 2 years per subject-month | Any reported episode of large volume (≥ 5 L) paracentesis following the TIPS procedure. | LVP frequency will be analyzed at 1, 3, 6, 12, and 24 months. |
| Change in Quality of Life from baseline | Change in Quality of Life as measured by the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Chronic Liver Disease Questionnaire (CLDQ). | Baseline and 1, 3, 6, 12, and 24 months |