Registry for the GORE® VIATORR® TIPS Device in Chronic Liver Disease
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
This study is testing how well the GORE® VIATORR® TIPS device works and keeps patients safe over three years for people with chronic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 196 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | W.L.Gore & Associates Industry-sponsored |
| Locations | 7 sites (Vienna and 6 other locations) |
| Trial ID | NCT05661331 on ClinicalTrials.gov |
What this trial studies
This registry aims to confirm the clinical performance and safety of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion over a functional lifetime of three years in a real-world setting. It will also collect data on patients' quality of life following treatment with this device. Patients will undergo a thorough screening process, including assessments of their medical history, physical examination, and various scoring systems related to liver disease. The registry will enroll patients who meet specific inclusion criteria and provide informed consent.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older who are eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis.
Not a fit: Patients who are unable or unwilling to provide informed consent or those currently enrolled in another investigational study may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of the GORE® VIATORR® TIPS device's effectiveness and safety, potentially improving treatment options for patients with chronic liver disease.
How similar studies have performed: While this registry approach is not novel, it builds on existing knowledge of TIPS devices, and similar studies have shown promising results in assessing device performance and patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna and 6 other locations
- Medical University of Vienna - Department of Internal Medicine III — Vienna, Austria (Recruiting)
- Hôpital La Pitiè-Salpétrière — Paris, France (Recruiting)
- University Medical Center Freiburg, Department of Medicine II — Freiburg, Germany (Recruiting)
- Westfälische Wilhelms-Universität Münster — Münster, Germany (Recruiting)
- AOU Careggi — Firenze, Italy (Recruiting)
- University Hospital Modena — Modena, Italy (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Jonel Trebicka, Prof Dr med — Universitätsklinikum Münster
- Study coordinator: Valerie Jean, PhD
- Email: vjean@wlgore.com
- Phone: + 33 674742698
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.