Abdominal Aortic Aneurysm Clinical Trial
— EMBRACEOfficial title:
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
Verified date | December 2023 |
Source | W.L.Gore & Associates |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 259 |
Est. completion date | July 2026 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University | Aarhus | |
Denmark | Rigshospitalet | Copenhagen | |
Italy | IRCCS Ospedale Policlinico San Martino | Genova | |
Italy | "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele | Milano | |
Italy | Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata | Roma | |
Italy | Azienda Ospedaliera Universitaria Policlinico Umberto I | Roma | |
Netherlands | AMC, Meibergdreef 9 | Amsterdam | |
Norway | Haukeland Universitetssjukehus | Bergen | |
Norway | UNN Tromsø | Tromsø | |
Norway | St. Olavs Hospital | Trondheim | |
Spain | Hospital Clínico Universitario San Cecilio | Granada | |
Spain | Hospital Clinico San Carlos | Madrid | |
Sweden | Skane University Hospital | Malmö | |
Sweden | Uppsala University Hospital | Uppsala |
Lead Sponsor | Collaborator |
---|---|
W.L.Gore & Associates |
Denmark, Italy, Netherlands, Norway, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target vessel patency (patient level) | 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. | 12 months | |
Secondary | Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft) | Any repeated vascular or nonvascular procedure related to the index procedure | 12 months and annually through 5 years post-implant | |
Secondary | Target Vessel Technical Success | Successful catheterization and VBX Stent Graft placement in all intended target vessels | at the procedure | |
Secondary | Primary Technical Success (Total Endovascular 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) |
at the procedure | |
Secondary | Target vessel instability | 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 | 12 months and annually through 5 years post-implant | |
Secondary | Target vessel patency (patient level) | 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. | annually from 2-5 years post-implant | |
Secondary | Target vessel patency (vessel level analysis) | 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. | annually from procedure to 5 years post-implant | |
Secondary | Aneurysm-related mortality | 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 | at 12 months and annually through 5 years post-implant | |
Secondary | MAEs at 30 days | MAEs according to stardard definition. | 30 days post implant |
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