Clinical trial NCT05661331: VIATORR Device Registry
Official title: VIATORR Device Registry - Post-Market Clinical Follow-Up (PMCF) Registry of the GORE® VIATORR® TIPS Endoprosthesis With Controlled Expansion to Treat Portal Hypertension and Its Complications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Liver Disease
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2022-12-22
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for portal hypertension and its complications including, but not limited to, variceal bleeding and/or ascites.

Brief summary: The primary objective is to confirm the clinical performance and safety of the GORE® VIATORR® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis with Controlled Expansion throughout the device functional lifetime of 3 years in real world setting.

The secondary objective is to collect information on quality of life after treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion.

Additionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.

Detailed description: 1. 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
   * Medication
   * TIPS imaging per site standard
   * Adverse Events

   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.

Eligibility criteria: Inclusion Criteria:

1. Patient is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for TIPS creation
2. Patient is ≥18 years of age
3. Capable of complying with protocol requirements, including follow-up
4. Signed informed consent by patient

Exclusion Criteria:

1. Unable or not willing to sign informed consent
2. Patient is enrolled in an investigational study
3. Patient has been previously enrolled in this registry
4. Pregnant or breastfeeding female at time of informed consent signature
5. Any other condition which in the judgement of the investigator would preclude adequate registry participation

Primary outcomes:
measure: Shunt primary patency through 3 years
timeFrame: Through 3 years
Secondary outcomes:
measure: Technical success at day 0
timeFrame: Day 0 - Intervention
measure: Reduction in PSG at day 0
timeFrame: Day 0 - Intervention
measure: Variceal rebleeding through 3 years
timeFrame: Through 3 years
measure: Frequency of LVP (Large Volume Paracentesis) through 3 years
timeFrame: Through 3 years
measure: Quality of life (EQ-5D-5L) questionnaire compared to baseline at 1, 3, 6, 12, 24, 36 months
timeFrame: Through 3 years
measure: Quality of Life (CLDQ) questionnaire compared to baseline at 1, 3, 6, 12, 24, 36 months
timeFrame: Through 3 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna - Department of Internal Medicine III
city: Paris
country: France
facility: Hôpital La Pitiè-Salpétrière
city: Freiburg
country: Germany
facility: University Medical Center Freiburg, Department of Medicine II
city: Münster
country: Germany
facility: Westfälische Wilhelms-Universität Münster
city: Firenze
country: Italy
facility: AOU Careggi
city: Modena
country: Italy
facility: University Hospital Modena
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
affiliation: Universitätsklinikum Münster
name: Jonel Trebicka, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: