Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry

Launched by W.L.GORE & ASSOCIATES · May 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, a type of medical device used to treat various conditions affecting blood flow, such as Peripheral Artery Disease and aneurysms. The goal of the trial is to collect real-world data on how well this device works in patients after they receive it as part of their treatment. Researchers want to understand the outcomes and any potential benefits or issues that may arise from its use.

To participate in the trial, individuals must be at least 18 years old and provide their consent to join. They should also be deemed suitable for treatment with this device by their doctor. It's important for participants to be willing to follow the care guidelines set by the hospital or clinic. However, some people may not be eligible if they have certain medical conditions that could affect the trial results or if they cannot tolerate specific medications. Participants can expect regular follow-ups to monitor their health and how the device is working for them. Overall, this trial aims to enhance understanding of the device's effectiveness in everyday clinical settings.

Gender

ALL

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).