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Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Active Not RecruitingN/A
Sponsor: W.L.Gore & Associates
Conditions: Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms, Trauma Injury
Interventions: GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Countries: Belgium, France, Germany, Greece, Italy, Netherlands, Spain, Sweden
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility 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).
Locations (26)
- Sint-Agatha-Berchem, Belgium
- Angers, France
- Brest, France
- Lyon, France
- Paris, France
- Strasbourg, France
- Frankfurt, Germany
- Hamburg, Germany
- Heidelberg, Germany
- Reinbek, Germany
- Tübingen, Germany
- Pávlos, Greece
- Ancona, Italy
- Brescia, Italy
- Modena, Italy
- Torino, Italy
- Varese, Italy
- Arnhem, Netherlands
- Leeuwarden, Netherlands
- Barcelona, Spain
- Vigo, Spain
- Malmö, Sweden
- Solna, Sweden
- Bristol, United Kingdom
- Glasgow, United Kingdom
- London, United Kingdom