Back to Trials
NCT06218875Recruiting

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

W.L.Gore & Associates

Start Date

5/7/2024

Completion Date

9/30/2042

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

AAA - Abdominal Aortic Aneurysm

Locations

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas 72205

United States

University of California - Irvine

Irvine, California 92697

United States

University of Southern California

Los Angeles, California 90033

United States

University of Southern California

Los Angeles, California 90033

United States

Stanford University School of Medicine

Palo Alto, California 94304

United States

Stanford University School of Medicine

Stanford, California 94304

United States

Mount Sinai Vascular Institute

Miami Beach, Florida 33140

United States

University of South Florida

Tampa, Florida 33606

United States

University of South Florida

Tampa, Florida 33606

United States

VA Medical Center- Atlanta

Atlanta, Georgia 30033

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia 30322

United States

Augusta University Medical Center

Augusta, Georgia 30912

United States

Atlanta VA Medical Center

Decatur, Georgia 30033

United States

University of Chicago Hospital

Chicago, Illinois 60637

United States

Endeavor Health

Evanston, Illinois 60026

United States

St. Vincent Medical Group, Inc.

Indianapolis, Indiana 46260

United States

University of Louisville

Louisville, Kentucky 40202

United States

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana 70808

United States

University of Maryland - Baltimore

Baltimore, Maryland 21201

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

McLaren Heatlh Care Corporation

Bay City, Michigan 48708

United States

Corewell Health Medical Group West

Grand Rapids, Michigan 49546

United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota 55407

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

University of Missouri

Columbia, Missouri 65212

United States

Cox Health

Springfield, Missouri 65807

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03766

United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire 03766

United States

University at Buffalo, Research Foundation

Buffalo, New York 14203

United States

Mission Hospital

Asheville, North Carolina 28801

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina 27599

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Duke Universtiy Medical Center

Durham, North Carolina 27710

United States

Forsyth Medical Center

Winston-Salem, North Carolina 27103

United States

Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

University Hospitals - Cleveland Medical Center

Cleveland, Ohio 44106

United States

Portland VA Health Care System

Portland, Oregon 97239

United States

Portland VA Health Care System

Portland, Oregon 97239

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Prisma Health-Upstate

Greenville, South Carolina 29615

United States

Prisma Health-Upstate

Greenville, South Carolina 29615

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

HCA Healthcare Research Institute/Columbia Medical Center of Plano

Plano, Texas 75075

United States

Baylor Scott and White

Plano, Texas 75093

United States

Intermountain Health

Murray, Utah 84107

United States

Intermountain Health

Murray, Utah 84107

United States

University of Utah

Salt Lake City, Utah 84112

United States

University of Utah

Salt Lake City, Utah 84112

United States

Inova Health Care Services

Falls Church, Virginia 22042

United States

Sentara Heart Hospital

Norfolk, Virginia 23507

United States

Sentara Heart Hospital

Norfolk, Virginia 23507

United States

CAMC Health and Education and Research Institute, Inc

Charleston, West Virginia 25304

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

John Hunter Hospital

New Lambton Heights, New South Wales

Australia

Gold Coast Hospital and Health Services

Southport, Queensland

Australia

Flinders Medical Centre (Vascular Unit)

Bedford Park, South Australia

Australia

The Alfred Hospital

Melbourne, Victoria

Australia

Royal Perth Hospital

Perth,

Australia

Royal Prince Alfred Hospital

Sydney,

Australia

Medizinische Universitat Wien

Vienna,

Austria

Helsinki University Hospital (HYKS III)

Helsinki,

Finland

Helsinki University Hospital (HYKS III)

Helsinki,

Finland

Wellbeing Services County of Pirkanmaa Tampere University Hospital

Tampere,

Finland

Wellbeing Services County of Pirkanmaa

Tampere,

Finland

Tel Aviv Sourasky Medical Center

Tel Aviv,

Israel

Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona

Ancona,

Italy

Azienda Ospedaliero Universitaria Policlinico di Bari

Bari,

Italy

Azienda Ospedaliero Universitaria Policlinico di Bari

Bari,

Italy

Fondazione IRCCS Policlinico San Matteo

Pavia,

Italy

AOU Città della Salute e della Scienza di Torino Ospedale S.Giovanni Battista- Molinette

Torino,

Italy

Azienda Ospedaliera Universitaria Integrata Verona

Verona,

Italy

Amsterdam UMC Research BV

Amsterdam,

Netherlands

Stichting Elisabeth-Tweesteden Ziekenhuis

Tilburg,

Netherlands

VieCuri Medical Center

Venlo,

Netherlands

Clinical Trials New Zealand Limited - Waikato Hospital

Hamilton, Waikato Region

New Zealand

Auckland District Health Board Charitable Trust

Auckland,

New Zealand

Uniwersytecki Szpital Kliniczny NR 1 W Lublinie

Lublin,

Poland

Hospital De La Santa Creu i Sant Pau

Barcelona,

Spain

Hospital Universitario Virgen del Rocío

Seville,

Spain

Karolinska University Hospital

Stockholm,

Sweden

Karolinska University Hospital

Stockholm,

Sweden

University Hospitals of Leicester NHS Trust

Leicester,

United Kingdom

Countess of Chester Hospital NHS Foundation Trust

Liverpool,

United Kingdom

Countess of Chester Hospital NHS Foundation Trust

Liverpool,

United Kingdom

Imperial College Healthcare NHS Trust, St. Mary's Hospital

London,

United Kingdom

St Thomas Hospital - Guys and St. Thomas' NHS

London,

United Kingdom

St Thomas Hospital - Guys and St. Thomas' NHS

London,

United Kingdom