Ascites Hepatic, Hydrothorax, Liver Diseases, Portal Hypertension, Vascular Diseases
Conditions
Keywords
Transjugular Intrahepatic Portosystemic Shunt, TIPS, Portal Vein Access
Brief summary
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.
Interventions
Portal Vein Access with Scorpion or Scorpion X set
DEVICECook Transjugular Liver Access Set
Portal Vein Access with Ring or Rosch-Uchida set
Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Sponsors
Avania
Argon Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ≥ 18 years of age at the time of the TIPS procedure 2. TIPS procedure initiated for refractory variceal bleeding, refractory ascites and/or hydrothorax 3. Willing and able to provide written informed consent and HIPAA (Health Insurance Portability and Accountability Act) authorization 4. Willing and able to comply with the study procedures and follow up schedule
Exclusion criteria
1. Known active malignancy 2. MELD score ≥ 18 at time of screening 3. History of polycystic liver disease 4. Active bleeding from any source 5. Pulmonary hypertension, heart failure, severe tricuspid valve dysfunction, right to left cardiopulmonary shunt 6. Chronic, occlusive portal vein thrombosis or complete portal vein thrombosis of the main or target portal vein on prior CT examination 7. Active or uncontrolled hepatic encephalopathy 8. Systemic infection/sepsis 9. Biliary obstruction 10. Uncorrectable coagulopathy 11. Any diminutive or partially thrombosed right portal vein 12. Hepatic vein thrombosis (i.e., no Budd-Chiari syndrome) 13. Known sensitivity to contrast or serious contrast reaction such as anaphylaxis 14. Pregnant women or women who are planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | TIPS Procedure (Day 0), up to 93 minutes | Creation of the parenchymal tract between the hepatic vein and an intrahepatic branch of the portal vein confirmed by portogram (CO2/contrast). |
| Composite of Major Complications | Through 30 days post-TIPS procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Needle Passes | TIPS Procedure (Day 0), up to 93 minutes | Count of needle throws between the hepatic and portal vein to create the parenchymal tract. |
| Procedure Duration | TIPS Procedure (Day 0), up to 93 minutes | Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient. |
| Portal Vein Access (PVA) Time | TIPS Procedure (Day 0), up to 52 minutes | Time (in minutes) from the first forward motion of the needle to confirmation of portal vein access via portogram. |
| Device-Related Complications | Through 30 days post-TIPS procedure | Incidence of complications related to the device as judged by the Investigator |
| Fluoroscopy Time | TIPS Procedure (Day 0), up to 31.5 minutes | Measured in minutes |
| Number of Participants With Technical Success | TIPS Procedure (Day 0), up to 93 minutes | Creation of a shunt (stent bridging) between the portal and systemic veins. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 2 |
| 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) | 1 |
| Total | 3 |
Baseline characteristics
| Characteristic | TIPS With Scorpion Portal Vein Access Kit | TIPS With Cook Transjugular Liver Access Set | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 2 / 2 | 1 / 1 |
| serious Total, serious adverse events | 1 / 2 | 1 / 1 |
Outcome results
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.
Time frame: Through 30 days post-TIPS procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Composite of Major Complications | 0 Events |
| TIPS With Cook Transjugular Liver Access Set | Composite of Major Complications | 1 Events |
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).
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Population: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Number of Participants With Procedural Success | Yes | 2 Participants |
| TIPS With Scorpion Portal Vein Access Kit | Number of Participants With Procedural Success | No | 0 Participants |
| TIPS With Cook Transjugular Liver Access Set | Number of Participants With Procedural Success | Yes | 1 Participants |
| TIPS With Cook Transjugular Liver Access Set | Number of Participants With Procedural Success | No | 0 Participants |
Secondary
Device-Related Complications
Incidence of complications related to the device as judged by the Investigator
Time frame: Through 30 days post-TIPS procedure
Population: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Device-Related Complications | Subject ID 02-002 | 2 Number of AEs |
| TIPS With Scorpion Portal Vein Access Kit | Device-Related Complications | Subject ID 02-003 | 4 Number of AEs |
| TIPS With Cook Transjugular Liver Access Set | Device-Related Complications | Subject ID 02-001 | 2 Number of AEs |
Secondary
Fluoroscopy Time
Measured in minutes
Time frame: TIPS Procedure (Day 0), up to 31.5 minutes
Population: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Fluoroscopy Time | Subject ID 02-002 | 18.2 Minutes |
| TIPS With Scorpion Portal Vein Access Kit | Fluoroscopy Time | Subject ID 02-003 | 16.7 Minutes |
| TIPS With Cook Transjugular Liver Access Set | Fluoroscopy Time | Subject ID 02-001 | 31.5 Minutes |
Secondary
Number of Needle Passes
Count of needle throws between the hepatic and portal vein to create the parenchymal tract.
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Population: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Number of Needle Passes | Subject ID 02-002 | 1 Number of Needle Passes |
| TIPS With Scorpion Portal Vein Access Kit | Number of Needle Passes | Subject ID 02-003 | 1 Number of Needle Passes |
| TIPS With Cook Transjugular Liver Access Set | Number of Needle Passes | Subject ID 02-001 | 3 Number of Needle Passes |
Secondary
Number of Participants With Technical Success
Creation of a shunt (stent bridging) between the portal and systemic veins.
Time frame: TIPS Procedure (Day 0), up to 93 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Number of Participants With Technical Success | Yes | 2 Participants |
| TIPS With Scorpion Portal Vein Access Kit | Number of Participants With Technical Success | No | 0 Participants |
| TIPS With Cook Transjugular Liver Access Set | Number of Participants With Technical Success | Yes | 1 Participants |
| TIPS With Cook Transjugular Liver Access Set | Number of Participants With Technical Success | No | 0 Participants |
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.
Time frame: TIPS Procedure (Day 0), up to 52 minutes
Population: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Portal Vein Access (PVA) Time | Subject ID 02-002 | 7 minutes |
| TIPS With Scorpion Portal Vein Access Kit | Portal Vein Access (PVA) Time | Subject ID 02-003 | 8 minutes |
| TIPS With Cook Transjugular Liver Access Set | Portal Vein Access (PVA) Time | Subject ID 02-001 | 52 minutes |
Secondary
Procedure Duration
Interval (in minutes) from first jugular access for TIPS creation to removal of catheters from the patient.
Time frame: TIPS Procedure (Day 0), up to 93 minutes
Population: 2 participants with Scorpion Portal Vein Access Kit whereas 1 participant with Cook Transjugular Liver Access Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIPS With Scorpion Portal Vein Access Kit | Procedure Duration | Subject ID 02-002 | 35 Minutes |
| TIPS With Scorpion Portal Vein Access Kit | Procedure Duration | Subject ID 02-003 | 49 Minutes |
| TIPS With Cook Transjugular Liver Access Set | Procedure Duration | Subject ID 02-001 | 93 Minutes |