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Набира участници NCT06218875

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

Заболявания: AAA - Abdominal Aortic Aneurysm

Спонсор: W.L.Gore & Associates

Налично на: БГ
Обобщение
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.
Описание
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.
Кой може да участва
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.
Места на провеждане 11
Австралия (1)
John Hunter Hospital
New Lambton Heights , New South Wales
NOT_YET_RECRUITING
Финландия (1)
Helsinki University Hospital (HYKS III)
Helsinki
Израел (1)
Tel Aviv Sourasky Medical Center
Tel Aviv
Basheer Sheikh-Yousif, M.D.
Италия (1)
Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona
Ancona
Нидерландия (1)
Amsterdam UMC Research BV
Amsterdam
New Zealand (1)
Clinical Trials New Zealand Limited - Waikato Hospital
Hamilton , Waikato Region
Полша (1)
Uniwersytecki Szpital Kliniczny NR 1 W Lublinie
Lublin
NOT_YET_RECRUITING
Испания (1)
Hospital De La Santa Creu i Sant Pau
Barcelona
Швеция (1)
Karolinska University Hospital
Stockholm
Великобритания (1)
University Hospitals of Leicester NHS Trust
Leicester
САЩ (1)
Central Arkansas Veteran's Healthcare System
Little Rock , Arkansas
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
07.05.2024
Крайна дата
30.09.2042
Регистрационен номер
NCT06218875
Източник
anzctr
Запитване за медицински туризъм

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