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

Official title

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

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.

Detailed 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.

Primary outcome measures

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

Secondary outcome measures (2)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 56 centers

• 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
• … and 48 more centers

Australia · 6 centers

• 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

Italy · 6 centers

• 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

United Kingdom · 6 centers

Center list to be confirmed — check the primary protocol.

Finland · 4 centers

• 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

Netherlands · 3 centers

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

New Zealand · 2 centers

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

Spain · 2 centers

Center list to be confirmed — check the primary protocol.

Sweden · 2 centers

Center list to be confirmed — check the primary protocol.

Austria · 1 center

• Medizinische Universitat Wien — Vienna

Israel · 1 center

• Tel Aviv Sourasky Medical Center — Tel Aviv

Poland · 1 center

• Uniwersytecki Szpital Kliniczny NR 1 W Lublinie — Lublin

Identifiers

NCT: NCT06218875 · TGR 23-02AA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗