Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GOREĀ® VIABAHNĀ® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age ā„18 years
ā. Informed Consent Form (ICF) is signed by subject
ā. Suitable for endovascular treatment with the Reduced Profile GOREĀ® VIABAHNĀ® VBX Balloon Expandable Endoprosthesis (BXB) device
ā. Willingness of the subject to adhere to institutional standard of care follow-up requirements
Exclusion criteria
ā. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).
ā. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
ā. Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
ā. Life expectancy \<12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
ā. Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
ā. Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.
ā
What they're measuring
1
Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device
Timeframe: within 30 days after the treatment
2
Procedural Success for patients treated with BXB device
. Pregnant or breast-feeding subject at time of informed consent signature.
ā. Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).