Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB): This registry will collect data for eligible commercially available BXB device(s). The BXB device(s) will not be provided to the sites by the Sponsor. The BXB device implant procedure will be performed according to standard practice of the enrolling institution.
Study summary
Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years
2. Informed Consent Form (ICF) is signed by subject
3. Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device
4. Willingness of the subject to adhere to institutional standard of care follow-up requirements
Exclusion Criteria:
1. 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).
2. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
3. Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
4. Life expectancy \<12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
5. Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
6. 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.
7. Pregnant or breast-feeding subject at time of informed consent signature.
8. Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Primary outcome measure(s)
Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device — within 30 days after the treatment No adverse event that is deemed to be device-related and serious assessed by the investigator by cohort
Procedural Success for patients treated with BXB device — at the time of implant Successful access, delivery and deployment of BXB device, and withdrawal of catheters with patent BXB device at end of procedure
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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