Not provided
Not provided
Not provided
Not provided
Not provided
Low patient accrual
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Avania | INDUSTRY |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TIPS with Scorpion Portal Vein Access Kit | Active Comparator | Scorpion or Scorpion X access set |
|
| TIPS with Cook Transjugular Liver Access Set | Active Comparator | Ring or Rosch-Uchida access set |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scorpion Portal Vein Access Kit | Device | Portal Vein Access with Scorpion or Scorpion X set |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Procedural Success | Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast). | TIPS Procedure (Day 0), up to 93 minutes |
| 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 |
|---|---|---|
| Portal Vein Access (PVA) Time | Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram. | TIPS Procedure (Day 0), up to 52 minutes |
| Number of Participants With Technical Success |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Venkatesh P. Krishnasamy, MD | New York Presbyterian - Columbia University Medical Center | Principal Investigator |
| Danyel C Carr, MS | Argon Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States | ||
| New York Presbyterian - Columbia University Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TIPS With Scorpion Portal Vein Access Kit | Scorpion or Scorpion X access set Scorpion Portal Vein Access Kit: Portal Vein Access with Scorpion or Scorpion X set Transjugular Intrahepatic Portosystemic Shunt (TIPS): Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| FG001 | TIPS With Cook Transjugular Liver Access Set |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| 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 | May 10, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cook Transjugular Liver Access Set | Device | Portal Vein Access with Ring or Rosch-Uchida set |
|
| Transjugular Intrahepatic Portosystemic Shunt (TIPS) | Procedure | Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
|
Creation of a shunt (stent bridging) between the portal and systemic veins.
| TIPS Procedure (Day 0), up to 93 minutes |
| Number of Needle Passes | Count of needle throws between the hepatic and portal vein to create the parenchymal tract. | TIPS Procedure (Day 0), up to 93 minutes |
| Procedure Duration | Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient. | TIPS Procedure (Day 0), up to 93 minutes |
| Fluoroscopy Time | Measured in minutes | TIPS Procedure (Day 0), up to 31.5 minutes |
| Device-Related Complications | Incidence of complications related to the device as judged by the Investigator | Through 30 days post-TIPS procedure |
| New York |
| New York |
| 10032 |
| United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
Ring or Rosch-Uchida access set Cook Transjugular Liver Access Set: Portal Vein Access with Ring or Rosch-Uchida set Transjugular Intrahepatic Portosystemic Shunt (TIPS): Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TIPS With Scorpion Portal Vein Access Kit | Scorpion or Scorpion X access set Scorpion Portal Vein Access Kit: Portal Vein Access with Scorpion or Scorpion X set Transjugular Intrahepatic Portosystemic Shunt (TIPS): Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| BG001 | TIPS With Cook Transjugular Liver Access Set | Ring or Rosch-Uchida access set Cook Transjugular Liver Access Set: Portal Vein Access with Ring or Rosch-Uchida set Transjugular Intrahepatic Portosystemic Shunt (TIPS): Transjugular Intrahepatic Portosystemic Shunt (TIPS) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Procedural Success | Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast). | 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set | Posted | Number | Participants | TIPS Procedure (Day 0), up to 93 minutes |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | Events | Through 30 days post-TIPS procedure |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Portal Vein Access (PVA) Time | Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram. | 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set | Posted | Number | minutes | TIPS Procedure (Day 0), up to 52 minutes |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Technical Success | Creation of a shunt (stent bridging) between the portal and systemic veins. | Posted | Number | Participants | TIPS Procedure (Day 0), up to 93 minutes |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Needle Passes | Count of needle throws between the hepatic and portal vein to create the parenchymal tract. | 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set | Posted | Number | Number of Needle Passes | TIPS Procedure (Day 0), up to 93 minutes |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Procedure Duration | Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient. | 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set | Posted | Number | Minutes | TIPS Procedure (Day 0), up to 93 minutes |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Fluoroscopy Time | Measured in minutes | 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set | Posted | Number | Minutes | TIPS Procedure (Day 0), up to 31.5 minutes |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Device-Related Complications | Incidence of complications related to the device as judged by the Investigator | 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set | Posted | Number | Number of AEs | Through 30 days post-TIPS procedure |
|
|
Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TIPS With Scorpion Portal Vein Access Kit | Scorpion or Scorpion X access set Scorpion Portal Vein Access Kit: Portal Vein Access with Scorpion or Scorpion X set Transjugular Intrahepatic Portosystemic Shunt (TIPS): Transjugular Intrahepatic Portosystemic Shunt (TIPS) | 0 | 2 | 1 | 2 | 2 | 2 |
| EG001 | TIPS With Cook Transjugular Liver Access Set | Ring or Rosch-Uchida access set Cook Transjugular Liver Access Set: Portal Vein Access with Ring or Rosch-Uchida set Transjugular Intrahepatic Portosystemic Shunt (TIPS): Transjugular Intrahepatic Portosystemic Shunt (TIPS) | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Decreased activity | General disorders | Systematic Assessment |
|
The study was terminated early due to insufficient enrollment. Three (3) subjects were enrolled before the early termination leading to limited analyses.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danyel Carr | Argon Medical Devices | 469-731-1421 | Danyel.Carr@argonmedical.com |
| Oct 7, 2024 |
| Prot_SAP_000.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D019168 | Portasystemic Shunt, Transjugular Intrahepatic |
| ID | Term |
|---|---|
| D011170 | Portasystemic Shunt, Surgical |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|