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)
This is a prospective, multicenter, observational registry to collect real world data of the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) device. 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: * De novo or restenotic lesions in the iliac arteries including lesions at the aortic bifurcation \[Aortoiliac occlusive disease (AIOD)\], * De novo or restenotic lesions in the visceral arteries \[Visceral artery occlusive disease (VAOD)\], * Isolated visceral, iliac, and subclavian artery aneurysms \[IAA\], or * 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). Approximately 24 clinical investigative sites in Europe, will participate in this registry. 240 subjects will be implanted in this study with a limit of 48 subjects treated / implanted per site. If a site reaches 48 subjects, enrolment will be closed for that site. All subjects will be followed through 12 months (1 year) post-procedure per standard of care. Quality of Life questionnaires will also be collected for all follow-up visits.
Study Type
OBSERVATIONAL
Enrollment
240
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.
TUM Klinikum
Munich, Germany
RECRUITINGFreedom 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
Time frame: within 30 days after the treatment
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
Time frame: at the time of implant
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
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
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
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
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
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
Survival for patients treated in VAOD
Patient is free from death of any cause (is alive)
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
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Freedom from reintervention through 1 year follow-up for patients treated in Isolated Artery Aneurysm (Subclavian, Visceral, Iliac)
Freedom from unanticipated interventions on the target vessel(s) treated with the BXB Device.
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
30 Day Mortality for patients treated in IAA
all deaths, regardless of their relationship to the device, procedure, aneurysm, or unrelated medical conditions.
Time frame: from the time of the index procedure through 30 days
Treated vessel primary patency through 1 year follow-up for patients treated Trauma or Iatrogenic Vessel Injury
Blood flow through the target vessel without the need for repeat surgical or endovascular procedures
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
Device-related adverse events (i.e. thrombosis) for patients treated in Trauma or or Iatrogenic Vessel Injury
Stent thrombosis deemed to be device related as assessed by the Investigator.
Time frame: from the time of the index procedure up to 365 days (±window, between days 335 and 455)