An observational study in Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD) and Isolated Artery Aneurysms (IAA), sponsored by W.L.Gore & Associates. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by W.L.Gore & Associates · Observational
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:
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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 240 is above the median of 169 across 690 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
Device: Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) Intent to treat with Reduced Profile GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (BXB) in the treatment of Peripheral Artery Disease as part of routine clinical practice.
Device: 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.
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
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)
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)
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jan 2031, 56 months after the start.
Of 47 industry-sponsored observational studies under Wounds and Injuries, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 63. This study's planned 56 months is above that.
Counting every sponsor, half of 312 studies reached it within 28 months; a quarter within 12 and three quarters within 60.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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