Registry Procedures
1.1. Informed Consent Process All patients must provide informed consent prior to
any registry related procedures. The original signed informed consent form will be
retained in the subject records. A copy of the informed consent document will be
given to the subject.
1.1.1. Vulnerable Populations No vulnerable populations are included in this
registry. 1.1.2. Emergent Cases Emergent cases, in which prior informed consent of
the subject is not possible because of the subject's medical condition, can be
enrolled in this registry by signing the inform consent before discharge.
1.2. Enrollment The patient is considered enrolled when informed consent is
obtained. 1.3. Screening All patients who sign an informed consent will be
considered entered into the screening phase of the registry.
The following evaluations will be conducted:
Informed consent
Inclusion / exclusion criteria
Demographics
Medical history including o Primary: variceal bleeding (gastric or esophageal),
ascites (per EASL (European Association for the Study of the Liver)
guidelines), other o Secondary: variceal bleeding, ascites (per EASL
guidelines), hepatic hydrothorax, gastropathy, hepatorenal syndrome, other
Physical examination
Child-Pugh Score, MELD (Model for end-stage liver disease), MELD-Na (Model for
end-stage liver disease including sodium level), Clif C AD (Acute
Decompensation) Score.
Portal Hypertension details covering prior 12 months before ICF (Inform Consent
Form) signature
HE (Hepatic Encephalopathy) Assessment
Medication
Alcohol intake
Pregnancy test
EQ-5D-5L (Health Questionnaire - 5 dimensions) Questionnaire
CLDQ (Chronic Liver Disease Questionnaire) Questionnaire 1.4. Screen Failure If
the subject signed an informed consent and then is considered a screen failure
prior to procedure, the Subject Identification (ID) will be entered into the
Electronic Database Capture (EDC) system and the Inclusion / Exclusion Criteria
Case Report Form (CRF) will be completed to reflect criteria not met.
Additionally, the Completion / Discontinuation form has to be completed to
capture when the subject is no longer enrolled in the registry.
1.5. Procedure The GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
procedure will be performed according to standard practice of the enrolling
institution and the IFU (Instructions for Use).
No planned surgical concomitant procedures should be performed during the TIPS
procedure. If any unplanned surgical concomitant procedures are required during the
TIPS procedure the reason should be documented and entered into the Electronic Data
Capture (EDC) system.
The following details will be collected on the TIPS placement:
• Access vein, starting vein and portal vein entry location
TIPS set used
Pre- and post-dilation details
Additional procedures performed
PSG (Portosystemic Gradient) measurements
Completion imaging (per site standard)
Adverse Events (as occurred) Any implanted GORE® VIATORR® TIPS Endoprosthesis
with Controlled Expansion will be recorded on the subject's Procedure and
Device Accountability electronic Case Report Forms (eCRFs). If a GORE® VIATORR®
TIPS Endoprosthesis with Controlled Expansion was introduced into the
vasculature and not implanted as part of the registry procedure (e.g., no shunt
implant), the subject is considered an unsuccessful implant. The subject's
Procedure, AE (Adverse Event), Device Accountability, and Device Deficiency
eCRFs will be completed (as applicable), as well as a 30-day safety follow-up,
where only AEs will be collected. After this 30-day safety follow-up, the
Completion/Discontinuation form must be completed for patients with an
unsuccessful GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.
Any procedural complications arising after enrollment of an eligible subject (signed
ICF) will be treated per investigator's best medical judgment and recorded in the
EDC system as an AE.
1.6. HE Assessment Hepatic encephalopathy diagnosis detail should include covert and
overt classification, history of recurrent HE prior to TIPS, HE diagnosis at time of
TIPS, or HE at any time following TIPS procedure. Detail will be also collected on
the HE medication therapy.
1.7. Concomitant Medication Medication detail collected should include albumin,
antibiotics, antivirals, alcohol dependence medication,
antiplatelets/antithrombotics, chelating agents, corticosteroids, blood coagulation,
diuretics, somatostatins, Proton Pump Inhibitors, laxatives, and beta-blockers.
1.8. Imaging Images might be requested from sites for safety follow-up reasons. 1.9.
Repeat Interventions Repeat interventions performed on the original pathology or
directly on the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion
following the initial treatment will be recorded in the EDC system. The underlying
cause for repeat interventions should be recorded as an AE along with the treatment
as specified.
The following details will be collected on the TIPS revision:
Access vein, starting vein and portal vein entry location
TIPS set used
Pre- and post-dilation details
Additional procedures performed
PSG measurements
Completion imaging (per site standard)
Adverse Events (as occurred) If the GORE® VIATORR® TIPS Endoprosthesis with
Controlled Expansion is completely removed as part of the reintervention, then
the subject is discontinued from the registry and should be followed as per the
treating physician's standard of care.
1.10. Follow Up The follow-up visits should be completed within an acceptable time
frame and in accordance with the protocol-defined visit windows.
Subjects will continue to be followed by the site's standard of care after
completion of the registry.
1.10.1. Discharge or Day 7 Visit The first visit after the procedure will be
performed at discharge or day 7 post-surgery, whatever comes first.
The following data will be collected during this visit:
• Portal Hypertension - update on any new or existing portal hypertension symptoms
and treatments since last visit
• HE Assessment
1.10.2. FU (Follow-Up) Visit at 1, 3, 6, 12, 24 and 36 Months During the Follow-Up
period, visits will be conducted per visit windows as listed above in Table 5.
The following data will be collected during the follow-up visits:
• Physical examination
• Child-Pugh Score, MELD, MELD-Na, Clif C AD Score
• Portal Hypertension - update on any new or existing portal hypertension symptoms
and treatments since last visit
• HE Assessment
• Medication
• EQ-5D-5L Questionnaire
• CLDQ Questionnaire
• TIPS imaging per site standard
- Adverse Events (as occurred) 1.11. Subject Questionnaires Two health-related
quality of life instruments will be used, EQ-5D-5L as a general instrument and
CLDQ as disease-specific instrument (Chronic Liver Disease Questionnaire).
1.12. Subject Withdrawal from the Registry A subject may withdraw from the registry
at any time and should notify the investigator in this event. The investigator may
also withdraw the subject from the registry at any time based on his / her medical
judgment.
If such withdrawal is due to problems related to the registry device safety or
performance, the investigator shall ask for the subject's permission to follow his /
her status / condition outside the clinical investigation.
1.13. Subject Lost to Follow Up A subject will be considered lost to follow up and
withdrawn from the registry once they have missed two consecutive follow-up visits
and three documented attempts have been made by the investigator or designee to
contact the subject or next of kin. One of the three documented attempts must
include a certified letter. The subject's end date will be the last date of contact
made with the subject.
1.14. Subject Registry Completion A subject has completed the registry once the
36-month follow-up visit has been performed. Any subject that does not complete
these requirements due to voluntary withdrawal, physician withdrawal, death, or any
other reason will be considered a withdrawal. Subjects who miss two consecutive
visits and three documented attempts will be considered lost to follow up. Subjects
will not be provided with any medical care by the sponsor after registry completion
or withdrawal.
Subjects with a liver transplant or abandonment of the implanted device will exit
the registry at that timepoint and no further follow-up information will be
collected from these subjects.