Clinical trial NCT05143138: 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
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Abdominal Aortic Aneurysm
Thoracic Aortic Aneurysm
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2021-12-03
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The registry has been designed with broad eligibility criteria to capture real-world data about GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis used as a Bridging Stent in conjunction with a branched/fenestrated stent graft to allow endovascular aneurysm repair.

Patients will be identified from hospital database.

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.

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.

Eligibility criteria: 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 outcomes:
measure: Target vessel patency (patient level)
timeFrame: 12 months
Secondary outcomes:
measure: Reintervention (total and reintervention that can be attributed to branches originally treated with the VBX Stent Graft)
timeFrame: 12 months and annually through 5 years post-implant
measure: Target Vessel Technical Success
timeFrame: at the procedure
measure: Primary Technical Success (Total Endovascular Procedure)
timeFrame: at the procedure
measure: Target vessel instability
timeFrame: 12 months and annually through 5 years post-implant
measure: Target vessel patency (patient level)
timeFrame: annually from 2-5 years post-implant
measure: Target vessel patency (vessel level analysis)
timeFrame: annually from procedure to 5 years post-implant
measure: Aneurysm-related mortality
timeFrame: at 12 months and annually through 5 years post-implant
measure: MAEs at 30 days
timeFrame: 30 days post implant
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: "Vita-Salute" San Raffaele University I.R.C.C.S Ospedale San Raffaele
city: Roma
country: Italy
facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni Addolorata
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I
city: Amsterdam
country: Netherlands
facility: AMC, Meibergdreef 9
city: Bergen
country: Norway
facility: Haukeland Universitetssjukehus
city: Tromsø
country: Norway
facility: UNN Tromsø
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Granada
country: Spain
facility: Hospital Clínico Universitario San Cecilio
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Malmö
country: Sweden
facility: Skane University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: spedali civili brescia
name: Luca Bertoglio, Prof
role: PRINCIPAL_INVESTIGATOR
References: