Trial Outcomes & Findings for Achieving Portal Access With Scorpion Post-Approval Study (APASS) (NCT NCT05765253)
NCT ID: NCT05765253
Last Updated: 2024-12-11
Results Overview
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
TIPS Procedure (Day 0), up to 93 minutes
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
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)
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Achieving Portal Access With Scorpion Post-Approval Study (APASS)
Baseline characteristics by cohort
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TIPS Procedure (Day 0), up to 93 minutesPopulation: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast).
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Number of Participants With Procedural Success
Yes
|
2 Participants
|
1 Participants
|
|
Number of Participants With Procedural Success
No
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Through 30 days post-TIPS procedureMajor 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.
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Composite of Major Complications
|
0 Events
|
1 Events
|
SECONDARY outcome
Timeframe: TIPS Procedure (Day 0), up to 52 minutesPopulation: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram.
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Portal Vein Access (PVA) Time
Subject ID 02-001
|
—
|
52 minutes
|
|
Portal Vein Access (PVA) Time
Subject ID 02-002
|
7 minutes
|
—
|
|
Portal Vein Access (PVA) Time
Subject ID 02-003
|
8 minutes
|
—
|
SECONDARY outcome
Timeframe: TIPS Procedure (Day 0), up to 93 minutesCreation of a shunt (stent bridging) between the portal and systemic veins.
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Number of Participants With Technical Success
Yes
|
2 Participants
|
1 Participants
|
|
Number of Participants With Technical Success
No
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: TIPS Procedure (Day 0), up to 93 minutesPopulation: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Number of Needle Passes
Subject ID 02-001
|
—
|
3 Number of Needle Passes
|
|
Number of Needle Passes
Subject ID 02-002
|
1 Number of Needle Passes
|
—
|
|
Number of Needle Passes
Subject ID 02-003
|
1 Number of Needle Passes
|
—
|
SECONDARY outcome
Timeframe: TIPS Procedure (Day 0), up to 93 minutesPopulation: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Procedure Duration
Subject ID 02-001
|
—
|
93 Minutes
|
|
Procedure Duration
Subject ID 02-002
|
35 Minutes
|
—
|
|
Procedure Duration
Subject ID 02-003
|
49 Minutes
|
—
|
SECONDARY outcome
Timeframe: TIPS Procedure (Day 0), up to 31.5 minutesPopulation: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
Measured in minutes
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Fluoroscopy Time
Subject ID 02-001
|
—
|
31.5 Minutes
|
|
Fluoroscopy Time
Subject ID 02-002
|
18.2 Minutes
|
—
|
|
Fluoroscopy Time
Subject ID 02-003
|
16.7 Minutes
|
—
|
SECONDARY outcome
Timeframe: Through 30 days post-TIPS procedurePopulation: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
Incidence of complications related to the device as judged by the Investigator
Outcome measures
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 Participants
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 Participants
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)
|
|---|---|---|
|
Device-Related Complications
Subject ID 02-002
|
2 Number of AEs
|
—
|
|
Device-Related Complications
Subject ID 02-003
|
4 Number of AEs
|
—
|
|
Device-Related Complications
Subject ID 02-001
|
—
|
2 Number of AEs
|
Adverse Events
TIPS With Scorpion Portal Vein Access Kit
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
TIPS With Cook Transjugular Liver Access Set
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 participants at risk
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 participants at risk
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)
|
|---|---|---|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/2 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
100.0%
1/1 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
0.00%
0/1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
|
General disorders
Oedema peripheral
|
50.0%
1/2 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
0.00%
0/1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
0.00%
0/1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
Other adverse events
| Measure |
TIPS With Scorpion Portal Vein Access Kit
n=2 participants at risk
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)
|
TIPS With Cook Transjugular Liver Access Set
n=1 participants at risk
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)
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
100.0%
1/1 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
50.0%
1/2 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
0.00%
0/1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
1/2 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
0.00%
0/1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
|
General disorders
Decreased activity
|
50.0%
1/2 • Number of events 1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
0.00%
0/1 • Adverse event reporting started at the time of the TIPS procedure (on Day 0) and ended at Day 30.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place