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Creation of the parenchymal tract between the portal vein and the hepatic vein is the most difficult and time consuming step in a TIPS procedure. The purpose of this study is to evaluate portal vein access sets during the TIPS procedure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scorpion Portal Vein Access Kit | Device | Procedure/Surgery: Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Technical Success | Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein and confirmed by portogram | TIPS Procedure |
| Composite of Major Complications | Major complications associated with the procedure or study device and defined as complications resulting in an unplanned increase in the level of care, prolonged hospitalization, permanent adverse sequelae, or death. | Through 30 days post-TIPS procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Procedural Success | Successful delivery of the shunt | TIPS Procedure |
| Device-Related Complications | Incidence of complications related to the device as judged by the Investigator |
| Measure | Description | Time Frame |
|---|---|---|
| Portal Vein Access (PVA) Time | Time (in minutes) from hepatic vein access to portal vein access | TIPS Procedure |
| Procedure duration | Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from subject |
Inclusion Criteria:
1. Scorpion or Scorpion X kit introduced into the vasculature as the initial device for portal vein access
Exclusion Criteria:
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The procedure date window for the retrospective data was from 01-Feb-2022 to 05-Feb-2024.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2024 | Feb 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D008107 | Liver Diseases |
| D006876 | Hydrothorax |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D002318 | Cardiovascular Diseases |
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| Through 30 days post-TIPS procedure |
| TIPS Procedure |
| Fluoroscopy Time | Measured in minutes | TIPS Procedure |
| Change in MELD score | Change in score from Baseline Characteristics to Follow Up Data | up to 30 days post-TIPs procedure |
| Change in Child-Pugh score | Change in score from Baseline Characteristics to Follow Up Data | up to 30 days post-TIPs procedure |