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

Last updated: August 7, 2024
Sponsor: W.L.Gore & Associates
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Heart Disease

Cardiovascular Disease

Treatment

N/A

Clinical Study ID

NCT06218875
TGR 23-02AA
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient or legally authorized representative (LAR) provides written authorizationand/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

Exclusion Criteria:

  1. Patient who is, at the time of consent, unlikely to be available for standard ofcare (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/ordevice study within 12 months of Together Registry enrollment. Subjects cannot beenrolled in another Together Registry module protocol.

Study Design

Total Participants: 3500
Study Start date:
May 07, 2024
Estimated Completion Date:
September 30, 2042

Study 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.

Connect with a study center

  • Medizinische Universitat Wien

    Vienna,
    Austria

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • VU Medical Center Amsterdam

    Amsterdam,
    Netherlands

    Active - Recruiting

  • VieCuri Medical Center

    Venlo,
    Netherlands

    Active - Recruiting

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • McLaren Heatlh Care Corporation

    Bay City, Michigan 48708
    United States

    Active - Recruiting

  • Mission Hospital

    Asheville, North Carolina 28801
    United States

    Active - Recruiting

  • Columbia Medical Center of Plano

    Plano, Texas 75075
    United States

    Active - Recruiting

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