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Recruiting NCT06218875

Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Conditions: AAA - Abdominal Aortic Aneurysm

Sponsor: W.L.Gore & Associates

trial.available_in: БГ
Overview
A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.
Description
The purpose of the Gore Together Aortic Registry is to collect real-world data (RWD) for Gore aortic endovascular devices. Due to the nature of the program, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions. Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.
Who can participate
Inclusion Criteria: 1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements 2. Patient has been or is intended to be treated with an eligible registry device 3. Patient is age ≥ 18 years at time of informed consent signature. Exclusion Criteria: 1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures. 2. Patient with exclusion criteria required by local law. 3. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.
Locations 11
Australia (1)
John Hunter Hospital
New Lambton Heights , New South Wales
NOT_YET_RECRUITING
Finland (1)
Helsinki University Hospital (HYKS III)
Helsinki
Israel (1)
Tel Aviv Sourasky Medical Center
Tel Aviv
Basheer Sheikh-Yousif, M.D.
Italy (1)
Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona
Ancona
Netherlands (1)
Amsterdam UMC Research BV
Amsterdam
New Zealand (1)
Clinical Trials New Zealand Limited - Waikato Hospital
Hamilton , Waikato Region
Poland (1)
Uniwersytecki Szpital Kliniczny NR 1 W Lublinie
Lublin
NOT_YET_RECRUITING
Spain (1)
Hospital De La Santa Creu i Sant Pau
Barcelona
Sweden (1)
Karolinska University Hospital
Stockholm
United Kingdom (1)
University Hospitals of Leicester NHS Trust
Leicester
United States (1)
Central Arkansas Veteran's Healthcare System
Little Rock , Arkansas
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.05.2024
Completion date
30.09.2042
Registry ID
NCT06218875
Source
anzctr
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