observational gore® viabahn® endoprosthesis with propaten bioactive surface global registry

Conditions: Peripheral Artery Disease; Popliteal Aneurysm; Hemodialysis Access; Visceral Artery Aneurysms; Trauma Injury

Summary: collect real-world post-market clinical follow-up data on patients treated with the gore® viabahn® endoprosthesis with propaten bioactive surface (vsx)

this is an observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the gore® viabahn® endoprosthesis with propaten bioactive surface (vsx) for one of the following indications: 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. approximately 35 sites in europe will participate and a minimum of 614 patients will be enrolled in this registry. all consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the gore® viabahn® endoprosthesis with propaten bioactive surface (vsx) will be included and followed through one year for trauma/injury and other; three years for vaa; five years for iliac, sfa, sfa isr and av access and ten years for paa per institutional standard of care.

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).

Keywords: viabahn evar propaten iliac sfa sfa isr av access vaa paa trauma injury