Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis: Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
Study summary
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair from 31 December 2021 until 01 January 2017
2. Age ≥18 years at the time of implant
3. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at registry entry, unless a waiver was granted), according to local regulations.
Exclusion Criteria:
1. Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure
2. Patient treated for acute or sub-acute dissection, \<90 days from onset of symptoms
3. Patient treated using physician-modified endovascular grafts
4. Patient intended to be treated with chimney, periscope, octopus, sandwich technique per the pre-treatment case plan
5. At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment
6. Patient was pregnant at the time of treatment.
7. Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints.
8. Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.
Primary outcome measure(s)
Number of Participants With Target Vessel Patency — 12 months Uninterrupted patency with no occlusion or procedure performed to maintain patency on the VBX Stent Graft or native target vessel. Interventions intended to treat endoleak or stent disconnection do not count as loss of primary patency. Binomial proportions were calculated at 12 month follow-up.
Trial sites (14)
Facility
City
Region
Status
Aarhus University
Aarhus
Denmark
Rigshospitalet
Copenhagen
Denmark
IRCCS Ospedale Policlinico San Martino
Genova
Italy
"Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele
Milan
Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata
Roma
Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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