Suspended

GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for Various Vascular Indications Registry

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Study Aim

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.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Accidental Injuries+8

+ Popliteal Artery Aneurysm

+ Aneurysm

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2021
See protocol details

Summary

Principal SponsorW.L.Gore & Associates
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleObservational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry
NCT04907240
Principal SponsorW.L.Gore & Associates
Last updated: February 3, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

614 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Accidental InjuriesPopliteal Artery AneurysmAneurysmArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesWounds and InjuriesPeripheral Vascular DiseasesAtherosclerosisPeripheral Arterial Disease

Criteria

4 inclusion criteria required to participate
Age ≥ 18 years

Signed informed consent form

Suitable for endovascular treatment with VSX based on treating physician's best medical judgment

Willingness of the patient to adhere to institutional standard of care follow-up requirements

12 exclusion criteria prevent from participating
Non-compliant lesions where full expansion of an angioplasty balloon catheter is not achievable during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.

Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.

Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).

Lesion requires treatment with an altered endoprosthesis or delivery system. (Do not cut the endoprosthesis. The endoprosthesis should only be placed and deployed using the supplied catheter system).

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Suspended

iD3 Medical cvba

Sint-Agatha-Berchem, BelgiumOpen iD3 Medical cvba in Google Maps
Suspended

Centre Hospitalier Unversitaire d'Angers

Angers, France
Suspended

Centre Hospitalier Regional Universitaire de Brest

Brest, France
Suspended

Hopital Edouard Herriot (HCL)

Lyon, France
Suspended26 Study Centers