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

Официальное название

Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis

Обзор

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.

Подробное 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.

Первичные конечные точки

• Deployment Technical Success [Срок оценки: Time of Surgery]
• Lesion-related Mortality [Срок оценки: Day 30 through Year 10]
• Lesion Rupture [Срок оценки: Time of Surgery through Year 10]
• Lesion Enlargement [Срок оценки: Time of Surgery through Year 10]
• Endoleaks [Срок оценки: Time of Surgery through Year 10]
• Device Migration [Срок оценки: Time of Surgery through Year 10]
• Loss of aortic / branch patency [Срок оценки: Time of Surgery through Year 10]
• New onset renal failure [Срок оценки: Time of Surgery through Day 30]
• Renal function deterioration [Срок оценки: Time of Surgery through Year 10]
• Device integrity events [Срок оценки: Time of Surgery through Year 10]

Вторичные конечные точки (2)

• Characterization of remote data collection to supplement follow-up activities [Срок оценки: Time of Surgery through Year 10]
• New onset buttock claudication / erectile dysfunction [Срок оценки: Time of Surgery through Year 1]

Критерии участия

Критерии включения

• Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements
• Patient has been or is intended to be treated with an eligible registry device
• Patient is age ≥ 18 years at time of informed consent signature.

Критерии исключения

• 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.
• Patient with exclusion criteria required by local law.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 56 центров

• Central Arkansas Veteran's Healthcare System — Little Rock
• University of California - Irvine — Irvine
• University of Southern California — Los Angeles
• University of Southern California — Los Angeles
• Stanford University School of Medicine — Palo Alto
• Stanford University School of Medicine — Stanford
• Mount Sinai Vascular Institute — Miami Beach
• University of South Florida — Tampa
• … и ещё 48 центров

Австралия · 6 центров

• John Hunter Hospital — New Lambton Heights
• Gold Coast Hospital and Health Services — Southport
• Flinders Medical Centre (Vascular Unit) — Bedford Park
• The Alfred Hospital — Melbourne
• Royal Perth Hospital — Perth
• Royal Prince Alfred Hospital — Sydney

Италия · 6 центров

• Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona — Ancona
• Azienda Ospedaliero Universitaria Policlinico di Bari — Bari
• Azienda Ospedaliero Universitaria Policlinico di Bari — Bari
• Fondazione IRCCS Policlinico San Matteo — Pavia
• AOU Città della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette — Torino
• Azienda Ospedaliera Universitaria Integrata Verona — Verona

Великобритания · 6 центров

Список центров уточняется — проверьте первичный протокол.

Финляндия · 4 центра

• Helsinki University Hospital (HYKS III) — Helsinki
• Helsinki University Hospital (HYKS III) — Helsinki
• Wellbeing Services County of Pirkanmaa Tampere University Hospital — Tampere
• Wellbeing Services County of Pirkanmaa — Tampere

Нидерланды · 3 центра

• Amsterdam UMC Research BV — Amsterdam
• Stichting Elisabeth-Tweesteden Ziekenhuis — Tilburg
• VieCuri Medical Center — Venlo

Новая Зеландия · 2 центра

• Clinical Trials New Zealand Limited - Waikato Hospital — Hamilton
• Auckland District Health Board Charitable Trust — Auckland

Испания · 2 центра

Список центров уточняется — проверьте первичный протокол.

Швеция · 2 центра

Список центров уточняется — проверьте первичный протокол.

Австрия · 1 центр

• Medizinische Universitat Wien — Vienna

Израиль · 1 центр

• Tel Aviv Sourasky Medical Center — Tel Aviv

Польша · 1 центр

• Uniwersytecki Szpital Kliniczny NR 1 W Lublinie — Lublin

Идентификаторы

NCT: NCT06218875 · TGR 23-02AA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗