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Clinical Trials in Spain / NCT05143138
Active, not recruiting Observational

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

NCT05143138 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-03-23
Last updated
2026-09-21

Condition(s) studied

Abdominal Aortic AneurysmThoracic Aortic Aneurysm

Investigational drug(s) / intervention(s)

GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

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)

Trial sites (14)

FacilityCityRegionStatus
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 Roma Italy
AMC, Meibergdreef 9 Amsterdam Netherlands
Haukeland Universitetssjukehus Bergen Norway
UNN Tromsø Tromsø Norway
St. Olavs Hospital Trondheim Norway
Hospital Clínico Universitario San Cecilio Granada Spain
Hospital Clinico San Carlos Madrid Spain
Skane University Hospital Malmö Sweden
Uppsala University Hospital Uppsala Sweden

More W.L.Gore & Associates trials in Spain

Other trials for the same condition

Official registry record

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.

View NCT05143138 on ClinicalTrials.gov ↗ ← All trials in Spain