Aorto-iliac Occlusive Disease (AIOD)NCT07279649
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
An observational study of Aorto-iliac Occlusive Disease (AIOD) and Visceral Artery Occlusive Disease (VAOD), run by W.L.Gore & Associates at 1 site in Germany.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD), Isolated Artery Aneurysms (IAA)
- What is being tested?
- Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
- Type of treatment
- Medical device
- How many people
- 240 participants
- Where
- 1 siteGermany
- Study dates
- 8 May 2026to Jan 2031
- How long will I take part?
- 12 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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.
- Known intolerance to anticoagulant and / or antiplatelet therapy at the time of the index procedure
- 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.
- Pregnant or breast-feeding subject at time of informed consent signature.
- Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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)
Read the detailed description
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.
- Conditions
- Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD), Isolated Artery Aneurysms (IAA), Trauma or Iatrogenic Vessel Injury
- Being tested
- Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
- Keywords
- Peripheral Vascular Disease, Peripheral Arterial Disease, Aneurysm, Cardiovascular Disease, Trauma, Injury, Iliac, BXB, Aortoiliac occlusive disease, Visceral artery occlusive disease, Iliac arteries, visceral arteries, subclavian artery aneurysms, iatrogenic vessel injuries, FEVAR, BEVAR, CERAB
- Medical subject headings
- Wounds and Injuries, Peripheral Vascular Diseases, Peripheral Arterial Disease, Aneurysm, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)Device
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 group | Role | What they receive |
|---|---|---|
| Aortoiliac Occlusive Disease: De novo or rest. lesions in the iliac arteries include aortic bifurcat | 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. Receives: Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) | |
| Visceral Artery Occlusive Disease (VAOD): De novo or restenotic lesions in the visceral arteries | 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. Receives: Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) | |
| Isolated Artery Aneurysmal Disease (IAA): Isolated visceral, iliac, and subclavian artery aneurysms | 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. Receives: Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) | |
| Trauma or Iatrogenic Vessel Injury: are located in the chest cavity, abdominal cavity, or pelvis | 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. Receives: Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) | |
| Other (subjects not fitting into the categories above) | 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. Receives: Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at the time of implant
Secondary outcomes (8)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: from the time of the index procedure up to 365 days (±window, between days 335 and 455)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start8 May 2026
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorto-iliac Occlusive Disease (AIOD)Studies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniele Branzan, Prof. Dr., Principal investigator, TUM Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279649
- Sponsor's protocol ID
- VBX 22-08
- Status last verified
- May 2026
- First submitted
- 1 Dec 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No