GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)

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)

Study Overview

• Status: Recruiting
• Conditions: Aorto-iliac Occlusive Disease (AIOD); Visceral Artery Occlusive Disease (VAOD); Isolated Artery Aneurysms (IAA); Trauma or Iatrogenic Vessel Injury
• Intervention / Treatment: Device: Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)

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.

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Cagla Selvan; Phone Number: +31 627 294 665; Email: cselvan@wlgore.com
• Study Contact Backup: Name: Valerie Jeans; Phone Number: +33(0)6 74 74 26 98; Email: vjean@wlgore.com

Study Locations

• Germany
  • Munich, Germany, 81675
    • Recruiting
    • TUM Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.
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.	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.
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	at the time of implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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)	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.	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.	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	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.	from the time of the index procedure up to 365 days (±window, between days 335 and 455)

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Daniele Branzan, Prof. Dr., TUM Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: December 1, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 12, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Peripheral Vascular Disease; Trauma; Aneurysm; Injury; Peripheral Arterial Disease; Iliac; Iliac arteries; BEVAR; FEVAR; Aortoiliac occlusive disease; BXB; Visceral artery occlusive disease; visceral arteries; subclavian artery aneurysms; iatrogenic vessel injuries; CERAB
• Additional Relevant MeSH Terms: Vascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Wounds and Injuries; Peripheral Arterial Disease; Aneurysm; Peripheral Vascular Diseases
• Other Study ID Numbers: VBX 22-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No