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

Abdominal Aortic Aneurysm Clinical Trial

— EMBRACE  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05143138
• Other study ID #: VBX 21-04
• Status: Recruiting
• Start date: March 23, 2022
• Est. completion date: July 2026

Study information

• Verified date: December 2023
• Source: W.L.Gore & Associates
• Contact: Cinzia Santin
• Phone: +393463645539
• Email: csantin[@]wlgore.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• 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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Intervention

Device:
• GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Patients treated with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis as a Bridging Stent

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

Denmark,  Italy,  Netherlands,  Norway,  Spain,  Sweden, 

Outcome

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