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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 196
- Locations
- 7
- Primary Endpoint
- Shunt primary patency through 3 years
Study Overview
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
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for TIPS creation
- •Patient is ≥18 years of age
- •Capable of complying with protocol requirements, including follow-up
- •Signed informed consent by patient
Exclusion Criteria
- •Unable or not willing to sign informed consent
- •Patient is enrolled in an investigational study
- •Patient has been previously enrolled in this registry
- •Pregnant or breastfeeding female at time of informed consent signature
- •Any other condition which in the judgement of the investigator would preclude adequate registry participation
Outcomes
Primary Outcomes
Shunt primary patency through 3 years
Time Frame: Through 3 years
Shunt primary patency is defined as freedom from reintervention due to shunt dysfunction (occlusion or thrombosis on imaging or significant stenosis confirmed by venography) or shunt occlusion. Intentional shunt occlusions of otherwise patent stents will not be considered a loss of primary patency. Shunt primary patency will be analyzed at 1, 3, 6, 12, 24 and 36 months. There is no formal hypothesis that will be tested for the primary endpoint. The analysis of the primary endpoint will be descriptive in nature.
Secondary Outcomes
- Technical success at day 0(Day 0 - Intervention)
- Reduction in PSG at day 0(Day 0 - Intervention)
- Variceal rebleeding through 3 years(Through 3 years)
- Frequency of LVP (Large Volume Paracentesis) through 3 years(Through 3 years)
- Quality of life (EQ-5D-5L) questionnaire compared to baseline at 1, 3, 6, 12, 24, 36 months(Through 3 years)
- Quality of Life (CLDQ) questionnaire compared to baseline at 1, 3, 6, 12, 24, 36 months(Through 3 years)