About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Informed Consent Form (ICF) is signed by subject
Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device
Willingness of the subject to adhere to institutional standard of care follow-up requirements
Disqualifiers
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).
Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
Life expectancy <12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.
Trial population
The registry population will include subjects presenting with clinical conditions consistent with the BXB device indications for use and in accordance with standard of care. The following subject cohorts will be included in the registry: * Aortoiliac occlusive disease (AIOD) * Visceral artery occlusive disease VAOD) * Isolated visceral, iliac, and subclavian artery aneurysms \[IAA\] * Traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries) \[Arterial Injury (AI) * To satisfy a key objective of the PMCF plan, clinical data will be collected in other indications outside of those listed above (Other cohort) The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only subjects who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled.
Trial design
Cohort
Prospective
Treatments tested in this trial
Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
DeviceThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Freedom from device-related Serious Adverse Event (SAE) for patients treated with BXB device
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
Successful access, delivery and deployment of BXB device, and withdrawal of catheters with patent BXB device at end of procedure
Secondary outcomes
Primary patency for patients treated in Aortoiliac Occlusive Disease (AIOD) through 1 year follow-up
Blood flow through the target vessel without the need for repeat surgical or endovascular procedures
Freedom from major amputation of the BXB device treated limb for patients treated in AIOD
No amputation above the transmetatarsal level of the treated limb
Primary patency for patients treated in Visceral Occlusive Disease (VAOD)
Blood flow through the target vessel without the need for repeat surgical or endovascular procedures
Survival for patients treated in VAOD
Patient is free from death of any cause (is alive)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.