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NCT05811364 · ClinicalTrials.gov registry record · NA
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
A NA study of Peripheral Arterial Disease and Aortoiliac Occlusive Disease, sponsored by W.L.Gore & Associates.
- Recruiting
- Registry status
- NA
- Development phase
- 244
- Enrollment target
- 7
- Study locations
NCT05811364: Recruiting NA study of Peripheral Arterial Disease and Aortoiliac Occlusive Disease, sponsored by W.L.Gore & Associates.
NCT05811364 is a NA study of Peripheral Arterial Disease and Aortoiliac Occlusive Disease that is actively recruiting participants, run by W.L.Gore & Associates. The registered enrollment target is 244 participants, below the 4,203-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05811364, a NA study of Peripheral Arterial Disease and Aortoiliac Occlusive Disease, is actively recruiting participants, sponsored by W.L.Gore & Associates.
- RECRUITING
- Registry status
- NA
- Development phase
- 244 participants
- Enrollment target
- 7
- Study locations
Study Summary
The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
Primary Outcome
Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
Conditions Studied
Interventions
- DEVICE Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- DEVICE Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
Study Locations (7)
Other
- Krankenhaus der Barmherzigen Brüder - Regensburg
- Rijnstate Hospital - Arnhem
- Auckland City Hospital - Auckland
Colorado
- North Suburban Medical Center - Denver
Florida
- Radiology and Imaging Specialists of Lakeland - Lakeland
Pennsylvania
- University of Pennsylvania - Philadelphia
Texas
- The University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2032-01-31 |
| Phase | NA |
What NCT05811364 shows while recruiting
NCT05811364 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, below the 4,203-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is the first listed.
NCT05811364 lists 7 locations in 5 states (Other, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT05811364 about?
NCT05811364 is a clinical study titled "The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease". The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
What is the current status of trial NCT05811364?
This trial is currently recruiting. It is a NA study. The enrollment target is 244 participants. The study started on 2023-10-17. Estimated completion is 2032-01-31.
What conditions does trial NCT05811364 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Aortoiliac Occlusive Disease.
What interventions are being tested in trial NCT05811364?
The interventions under investigation include: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (DEVICE), Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent (DEVICE).
Who is sponsoring clinical trial NCT05811364?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05811364 being conducted?
This trial has 7 study locations across Colorado, Florida, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05811364's enrollment target sits among peer trials
244 19th of 79 higher than 61 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
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