NCT07279649

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2025-12-12
• Last updated: 2026-02-05

Locations

1 site across 1 country: Germany