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Registry for patients treated with GORE® VIABAHN® Endoprosthesis

Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface (VSX) Global Registry

Observational W.L.Gore & Associates · NCT04907240

This study is tracking how well the GORE® VIABAHN® Endoprosthesis works for patients with vascular conditions over time to see how it helps them.

Quick facts

Study typeObservational
Enrollment614 (estimated)
Ages18 Years and up
SexAll
SponsorW.L.Gore & Associates Industry-sponsored
Locations27 sites (Berchem-Sainte-Agathe and 26 other locations)
Trial IDNCT04907240 on ClinicalTrials.gov

What this trial studies

This observational registry collects real-world clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface. It is a multicenter study involving approximately 35 sites across Europe, enrolling a minimum of 614 patients. Participants will be followed for varying durations depending on their specific conditions, ranging from one to ten years. The study aims to assess the long-term outcomes and effectiveness of the endoprosthesis in treating various vascular conditions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are suitable for endovascular treatment with the GORE® VIABAHN® Endoprosthesis based on their physician's assessment.

Not a fit: Patients with non-compliant lesions or those requiring treatment with altered endoprostheses may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the long-term effectiveness and safety of the GORE® VIABAHN® Endoprosthesis, potentially improving treatment strategies for patients with vascular diseases.

How similar studies have performed: Other studies involving similar endoprosthetic devices have shown promising results, indicating that this approach is supported by prior successful outcomes.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥ 18 years
2. Signed informed consent form
3. Suitable for endovascular treatment with VSX based on treating physician's best medical judgment
4. Willingness of the patient to adhere to institutional standard of care follow-up requirements

Exclusion Criteria:

1. 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.
2. Use of the VSX Device in lesions involving a major side branch that may be covered by the endoprosthesis.
3. Lesion(s) cannot be treated with available VSX Device sizes per current Instructions for Use (IFU).
4. 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).
5. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or patient requires enrollment into more than one cohort) (Note: Only the first VSX treatment will be enrolled if concurrent VSX procedures are performed that would require enrollment into more than one cohort).
6. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
7. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
8. Unable to tolerate antiplatelet therapy.
9. Patient has a non-controllable allergy to contrast or the VSX Device components.
10. Pregnant or breast-feeding female at time of informed consent signature.
11. Life expectancy \< 12 months due to comorbidities.
12. Patient has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).

Where this trial is running

Berchem-Sainte-Agathe and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
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Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.