GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
DeviceTreatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
NCT Number: NCT06872905
The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Azienda Ospedaliero-Universitaria di Padova, Padova, Italy
A minimum of 158 adult subjects will be enrolled at up to a minimum of 20 sites in the U.S. and Europe. Data will be collected retrospectively and found within existing site files at Baseline, Treatment, Discharge, Pre-12-Month Follow-up, 12-Month Follow-Up, Subsequent Follow-Up Visits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-
Treatment of Target Lesions with the VBX Device in the aortic and common iliac positions during the CERAB procedure.
Time frame: 1-Year
Proportion of patients maintaining primary patency at 1 Year
Time frame: 30-Day
Proportion of patients experiencing any major adverse cardiovascular event (i.e. myocardial infarction, cerebrovascular accident) or event requiring reintervention.
Time frame: At index procedure
Proportion of patients with technical success
Time frame: 30-Day
Proportion of patients with all cause death
Time frame: 1 year
Proportion of patients achieving Primary Patency
Time frame: 1 year
Proportion of patients achieving Primary Assisted patency
Time frame: 1 year
Proportion of patients achieving Secondary Patency
Time frame: 1 year
Proportion of patients achieving freedom from Target Lesion Revascularization
Time frame: 1 Year
Proportion of patients survival
Time frame: 1 year
Proportion of patients achieving freedom from Clinically-Driven Target Revascularization
Contact information is provided by the study sponsor or research team.
Chris Timberlake, BS
CONTACT
Jennifer Camoriano, BS
CONTACT
W.L.Gore & Associates
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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