New stent graft registry aims to track safety in real patients
NCT ID NCT07279649
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This registry is following 240 people who receive the GORE VIABAHN VBX stent graft to treat blocked or damaged arteries in the abdomen, pelvis, or limbs. Researchers are tracking how well the device works and any serious side effects over time. The goal is to see if the stent graft performs safely in everyday medical practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GORE VIABAHN VBX balloon expandable stent graft
- What this could lead to
- If successful, this registry could confirm that the VBX stent graft is safe and effective for treating blocked or damaged arteries in routine practice.
- What could go wrong
- This is an observational registry, not a controlled trial, so results may be influenced by patient selection and site practices. It does not compare the device to other treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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TUM Klinikum
RECRUITINGMunich, 81675, Germany