GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry
NCT ID: NCT07279649
Last Updated: 2025-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
240 participants
OBSERVATIONAL
2026-06-30
2031-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Daniele Branzan, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
TUM Klinikum
Locations
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TUM Klinikum
Munich, , Germany
Countries
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Central Contacts
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Other Identifiers
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VBX 22-08
Identifier Type: -
Identifier Source: org_study_id
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