GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for Various Vascular Indications Registry
This study aims to observe the safety of the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) in various vascular conditions, specifically focusing on the absence of device-related serious adverse events.
Data Collection
Collected from today forward - ProspectiveAccidental Injuries+8
+ Popliteal Artery Aneurysm
+ Aneurysm
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 9, 2021
Actual date on which the first participant was enrolled.This study focuses on observing patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX), a special type of stent. The stent is used for various conditions such as Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. The study involves around 35 sites in Europe and aims to enroll a minimum of 614 patients. Its main goal is to gather real-world data on the stent's performance and safety in these diverse applications, potentially improving treatment strategies for these conditions. During the study, participants will be followed for varying periods depending on their condition, ranging from one year for Trauma/Injury and other conditions, up to ten years for Popliteal Artery Aneurysms (PAA). The primary outcome measured is the freedom from device-related serious adverse events (SAE). This means the study will track whether any significant issues occur that are directly related to the use of the stent. The study will assess these outcomes based on the investigator's evaluation.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.614 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 26 locations
Centre Hospitalier Unversitaire d'Angers
Angers, FranceCentre Hospitalier Regional Universitaire de Brest
Brest, FranceHopital Edouard Herriot (HCL)
Lyon, France