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

NCT06218875 | Recruiting DMC

• 1 other identifier: TGR 23-02AA
• Study Type: observational
• Target: 2,000
• Locations: 11 countries
• Sites: 84

Brief 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.

Conditions

AAA - Abdominal Aortic Aneurysm

Keywords

Aneurysm; Aneurysm Repair; Endovascular; EVAR; Endoprosthesis; Aortic; Aortic Repair

Outcome Measures

Primary Outcomes (11)

• Deployment Technical Success

  Successful access, delivery, and accurate deployment of the device to the intended location, and retrieval of the delivery system.

  Time of Surgery

• Lesion-related Mortality

  Death related to the index endovascular procedure, secondary procedure associated with the index lesion or the registry device, or any death where the treated disease / index lesion or registry device caused or significantly contributed to the death

  Day 30 through Year 10

• Lesion Rupture

  Rupture in the treated segment of the vessel (e.g., aorta or branch) verified with direct observation or Computed Tomographic Angiography (CTA) scan

  Time of Surgery through Year 10

• Lesion Enlargement

  An increase in maximum vessel (e.g., aorta or treated branch) diameter of \> 5 mm in the region encompassed by the initial lesion as compared to baseline using orthogonal (i.e., perpendicular to the centerline) measurements on CTA scans

  Time of Surgery through Year 10

• Endoleaks

  Perfusion of a treated lesion identified through imaging analysis

  Time of Surgery through Year 10

• Device Migration

  Longitudinal movement of all or part of the device for a distance ≥ 10 mm, as confirmed by CTA scan, relative to anatomical landmarks and device positioning at the first post-operative CTA scan.

  Time of Surgery through Year 10

• Loss of aortic / branch patency

  No flow or contrast detected through the implanted aortic and/or branch component (for branched devices) confirmed with imaging and/or direct observation.

  Time of Surgery through Year 10

• New onset renal failure

  New onset sustained renal failure identified within 30 days of the index endovascular procedure, combined with requiring dialysis for \> 4 weeks

  Time of Surgery through Day 30

• Renal function deterioration

  New onset of a decrease in eGFR \> 30% following treatment when compared to baseline eGFR.

  Time of Surgery through Year 10

• Device integrity events

  wire fractures, stent kinking, disruption/tears in the graft component, or stent compression or invagination identified through imaging analysis

  Time of Surgery through Year 10

• Reintervention

  Additional surgical or interventional procedure related to the treated disease / index lesion, the registry device, or to the treatment / procedure.

  Time of Surgery through Year 10

Secondary Outcomes (2)

• Characterization of remote data collection to supplement follow-up activities

  Time of Surgery through Year 10

• New onset buttock claudication / erectile dysfunction

  Time of Surgery through Year 1

Study Arms (2)

GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device)

Patients treated with the EXCC Device

GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device)

Patients treated with the IBE Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registry participants are derived from patients presenting with vascular disease that may benefit from the placement of an endovascular stent graft. The target registry population is patients who are treated with either EXCC or IBE Device at participating sites. This includes initial procedures and reinterventions (regardless of original intervention). Only patients who meet all the inclusion and none of the exclusion criteria will be included in the registry. The registry has been designed with broad eligibility criteria to optimize the visibility of overall registry device use. An integral requirement to the target subject population is that the decision to use a GORE® EXCLUDER® product has been made prior to considering the patient for possible registry participation.

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (90)

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72205, United States

RECRUITING

University of California - Irvine

Irvine, California, 92697, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Stanford University School of Medicine

Palo Alto, California, 94304, United States

RECRUITING

Stanford University School of Medicine

Stanford, California, 94304, United States

RECRUITING

Mount Sinai Vascular Institute

Miami Beach, Florida, 33140, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

VA Medical Center- Atlanta

Atlanta, Georgia, 30033, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Augusta University Medical Center

Augusta, Georgia, 30912, United States

RECRUITING

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

RECRUITING

University of Chicago Hospital

Chicago, Illinois, 60637, United States

RECRUITING

Endeavor Health

Evanston, Illinois, 60026, United States

RECRUITING

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, 46260, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

RECRUITING

University of Maryland - Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

McLaren Heatlh Care Corporation

Bay City, Michigan, 48708, United States

RECRUITING

Corewell Health Medical Group West

Grand Rapids, Michigan, 49546, United States

RECRUITING

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

University of Missouri

Columbia, Missouri, 65212, United States

RECRUITING

Cox Health

Springfield, Missouri, 65807, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

University at Buffalo, Research Foundation

Buffalo, New York, 14203, United States

RECRUITING

Mission Hospital

Asheville, North Carolina, 28801, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Duke Universtiy Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

University Hospitals - Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Portland VA Health Care System

Portland, Oregon, 97239, United States

RECRUITING

Portland VA Health Care System

Portland, Oregon, 97239, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Prisma Health-Upstate

Greenville, South Carolina, 29615, United States

RECRUITING

Prisma Health-Upstate

Greenville, South Carolina, 29615, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

HCA Healthcare Research Institute/Columbia Medical Center of Plano

Plano, Texas, 75075, United States

RECRUITING

Baylor Scott and White

Plano, Texas, 75093, United States

RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Inova Health Care Services

Falls Church, Virginia, 22042, United States

RECRUITING

Sentara Heart Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Sentara Heart Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

CAMC Health and Education and Research Institute, Inc

Charleston, West Virginia, 25304, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

NOT YET RECRUITING

Gold Coast Hospital and Health Services

Southport, Queensland, Australia

RECRUITING

Flinders Medical Centre (Vascular Unit)

Bedford Park, South Australia, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

RECRUITING

Royal Perth Hospital

Perth, Australia

RECRUITING

Royal Prince Alfred Hospital

Sydney, Australia

NOT YET RECRUITING

Medizinische Universitat Wien

Vienna, Austria

RECRUITING

Helsinki University Hospital (HYKS III)

Helsinki, Finland

RECRUITING

Helsinki University Hospital (HYKS III)

Helsinki, Finland

RECRUITING

Wellbeing Services County of Pirkanmaa Tampere University Hospital

Tampere, Finland

RECRUITING

Wellbeing Services County of Pirkanmaa

Tampere, Finland

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico di Bari

Bari, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico di Bari

Bari, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

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

Torino, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, Italy

RECRUITING

Amsterdam UMC Research BV

Amsterdam, Netherlands

RECRUITING

Stichting Elisabeth-Tweesteden Ziekenhuis

Tilburg, Netherlands

RECRUITING

VieCuri Medical Center

Venlo, Netherlands

RECRUITING

Clinical Trials New Zealand Limited - Waikato Hospital

Hamilton, Waikato Region, New Zealand

RECRUITING

Auckland District Health Board Charitable Trust

Auckland, New Zealand

RECRUITING

Uniwersytecki Szpital Kliniczny NR 1 W Lublinie

Lublin, Poland

NOT YET RECRUITING

Hospital De La Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Spain

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

RECRUITING

Countess of Chester Hospital NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

Countess of Chester Hospital NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

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

London, United Kingdom

RECRUITING

St Thomas Hospital - Guys and St. Thomas' NHS

London, United Kingdom

RECRUITING

St Thomas Hospital - Guys and St. Thomas' NHS

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• S. Han

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Martin

CONTACT

928-864-2223; kgmartin@wlgore.com

A. Lekuti

CONTACT

928-864-3576; alekuti@wlgore.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): September 30, 2042
• Study Completion (Estimated): September 30, 2042
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Sharing of IPD will not routinely be performed and is contingent on an assessment of the researcher's proposal for novelty or value in advancing educational, quality or medical practice objectives in use of this data.
• Access Criteria: See above

Locations

IL (1); AU (1); IT (6); NL (3); ES (2); FI (4); NZ (2); US (56); PL (1); SE (2); GB (6)