EMBRACE: 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
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Up to 15 sites in Europe will be required to enroll a minimum of 220 patients that have had treatment with 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.
The registry procedures consist of two phases, retrospective phase and prospective phase.
The retrospective phase consists only of the collection of retrospective data (baseline, treatment and FU data) from the source documents available at the site from the time of the treatment until the enrollment date (ICF signature).
The prospective phase consists in collection of follow-up visits from the enrollment up to 5 years. The FU data collected prospectively can change from subject to subject depending on the index procedure date. Diagnostic imaging, treatment interventions, and follow up will be determined by physicians based on clinical practice standards.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| fEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a fenestrated stent graft to allow endovascular aneurysm repair |
Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
|
| bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched stent graft to allow endovascular aneurysm repair |
Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
|
| fEVAR and bEVAR Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent in conjunction with a branched and fenestrated stent graft to allow endovascular aneurysm repair |
Device: GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent
|
Outcome Measures
Primary Outcome Measures
- Target vessel patency (patient level) [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.
Secondary Outcome Measures
- Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft) [12 months and annually through 5 years post-implant]
Any repeated vascular or nonvascular procedure related to the index procedure
- Target Vessel Technical Success [at the procedure]
Successful catheterization and VBX Stent Graft placement in all intended target vessels
- Primary Technical Success (Total Endovascular Procedure) [at the procedure]
A modified technical success definition, requiring the following: Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels Patency of all aortic modular stent graft components and intended side branch components Absence of type I or type III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging (CTA, magnetic resonance angiography [MRA], or duplex ultrasound)
- Target vessel instability [12 months and annually through 5 years post-implant]
Death or rupture related to side branch complication (e.g., endoleak) or reintervention to treat a branch-related complication, including endoleak, disconnection, kink, stenosis, occlusion, or rupture
- Target vessel patency (patient level) [annually from 2-5 years post-implant]
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.
- Target vessel patency (vessel level analysis) [annually from procedure to 5 years post-implant]
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.
- Aneurysm-related mortality [at 12 months and annually through 5 years post-implant]
Any death that occurs within the first 30 days or any death that results from aneurysm rupture, aorta-related complications (eg, infection, occlusion, dissection, hematoma), or a complication of a secondary intervention
- MAEs at 30 days [30 days post implant]
MAEs according to stardard definition.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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 01 July 2021 until 01 January 2017
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Age ≥18 years at the time of implant
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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:
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Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable at the time of the procedure
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Patient treated for acute or sub-acute dissection, <90 days from onset of symptoms
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Patient treated using physician-modified endovascular grafts
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Patient treated with chimney, periscope octopus, sandwich technique
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At the time of treatment, patient had known coagulation disorders including hypercoagulability that were not amenable to treatment
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Patient was pregnant at the time of treatment.
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Participation in another drug or device investigational study within one year of device implant, that can confound the registry endpoints.
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Patient had known or suspected systemic infection (including treatment for mycotic aneurysm) at the time of implant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aarhus University | Aarhus | Denmark | 8200 | |
| 2 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 3 | IRCCS Ospedale Policlinico San Martino | Genova | Italy | 16132 | |
| 4 | "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele | Milano | Italy | 20132 | |
| 5 | Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata | Roma | Italy | 00184 | |
| 6 | AMC, Meibergdreef 9 | Amsterdam | Netherlands | 1105 | |
| 7 | Haukeland Universitetssjukehus | Bergen | Norway | 5021 | |
| 8 | UNN Tromsø | Tromsø | Norway | 9038 | |
| 9 | Hospital Clínico Universitario San Cecilio | Granada | Spain | 18016 | |
| 10 | Hospital Clinico San Carlos | Madrid | Spain | 28040 | |
| 11 | Skane University Hospital | Malmö | Sweden | 214 28 | |
| 12 | Uppsala University Hospital | Uppsala | Sweden | S-751 85 |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Principal Investigator: Luca Bertoglio, Prof, "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele Via Olgettina n. 60, 20132 Milano
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VBX 21-04