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

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).