Recruiting

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

Sponsor:

W.L.Gore & Associates

Code:

NCT06218875

Conditions

AAA - Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06218875

Start date

May 7, 2024

Status verified date

Feb, 2026

Completion date

Sep 30, 2042

Anticipated

Primary completion date

Sep 30, 2042

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

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 ]
Reintervention [ Time Frame: Time of Surgery through Year 10 ]

Central Contacts and Locations

Central contacts

Karen Martin

928-864-2223 kgmartin@wlgore.com

A. Lekuti

928-864-3576 alekuti@wlgore.com

Locations

Central Arkansas Veteran's Healthcare System

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Sandi Brock

501-257-6906 Sandra.Brock@va.gov

Principal Investigator:

Lauren Story-Hefta, M.D.

University of California - Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Lizette Spiers

714-456-5694 lspiers@hs.uci.edu

Principal Investigator:

Anthony Chau, M.D.

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Amarilis Bolanos

323-442-5763 amarilis.bolanos@med.usc.edu

Principal Investigator:

Sukgu Han, MD

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Amarillis Bolanos

323-442-5763 Amarilis.Bolanos@med.usc.edu

Principal Investigator:

Sukgu Han, M.D.

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Suneetha Atluri

650-561-5474 satluri2@stanford.edu

Principal Investigator:

Kenneth Tran, MD

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94304

Contacts

Suneetha Atluri

650-561-5474 satluri2@stanford.edu

Principal Investigator:

Kenneth Tran, M.D.

Mount Sinai Vascular Institute

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Eduardo Palmero

Eduardo.PalmeroSau@msmc.com

Principal Investigator:

Michael Ayad, M.D.

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Eric Johnson

813-505-4787 eej11@usf.edu

Principal Investigator:

Dean Arnaoutakis, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33606

Contacts

Eric Johnson

610-573-4814 eej11@usf.edu

Principal Investigator:

Dean Arnaoutakis, M.D.

VA Medical Center- Atlanta

Recruiting

Atlanta, Georgia, United States, 30033

Contacts

Elizabeth Tibus

470-551-0032 Elizabeth.Tibus@va.gov

Principal Investigator:

Olamide Alabi, M.D.

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Sonya Mathewson

404-274-2368 sbmathe@emory.edu

Principal Investigator:

James Chang, M.D.

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Sally El-Shafey

706-446-0303 SELSHAFEY@augusta.edu

Principal Investigator:

Gautam Agarwal, M.D.

Atlanta VA Medical Center

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Elizabeth Tibus

404-321-6111 elizabeth.tibus@va.gov

Principal Investigator:

Olamide Alabi, MD

University of Chicago Hospital

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Trissa Babrowski

312-774-1781 trissa.babrowski@uchospitals.edu

Principal Investigator:

Trissa Babrowski, M.D.

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60026

Contacts

Karen Hynes

847-503-5137 khynes@northshore.org

Principal Investigator:

CJ Lee, M.D.

St. Vincent Medical Group, Inc.

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Allyn Harker

317-338-6161 allyn.harker@ascension.org

Principal Investigator:

Brent Marsden, M.D.

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Leslie Haysley

502-852-2801 leslie.haysley@louisville.edu

Principal Investigator:

Amit Dwivedi, M.D.

Our Lady of the Lake Regional Medical Center

Recruiting

Baton Rouge, Louisiana, United States, 70808

Contacts

Becky Toler

225-765-7733 Rebecca.Toler@fmolhs.org

Principal Investigator:

P. Michael Davis, M.D.

University of Maryland - Baltimore

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kim Nordstrom

410-706-3037 KNordstrom@som.umaryland.edu

Principal Investigator:

Shahab Toursavadhohi, M.D.

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Monica Goyal

617-667-7000 mgoyal@bidmc.harvard.edu

Principal Investigator:

Marc Schermerhorn, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Fernando Moreno

617-632-8374 fmoreno@bidmc.harvard.edu

Monica Goyal

mgoyal@bidmc.harvard.edu

Principal Investigator:

Marc Schermerhorn, M.D.

McLaren Heatlh Care Corporation

Recruiting

Bay City, Michigan, United States, 48708

Contacts

Sara Vernon

989-891-8189 sara.vernon@mclaren.org

Principal Investigator:

Nicolas Mouawad, M.D.

Corewell Health Medical Group West

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

Tracy Wiles

616-391-8367 Tracy.Wiles@corewellhealth.org

Principal Investigator:

Eanas Yassa, M.D.

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Sara Behmanesh

612-863-6287 sara.behmanesh@allina.com

Principal Investigator:

Elliot Stephenson, M.D.

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sonja Riggs

507-422-6798 Riggs.Sonja@mayo.edu

Principal Investigator:

Jill Colglazier, M.D.

University of Missouri

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Hannah Sinek

573-884-3226 as8bc@health.missouri.edu

Principal Investigator:

Todd Vogel, M.D.

Cox Health

Recruiting

Springfield, Missouri, United States, 65807

Contacts

Christopher Schulze

417-269-7114 christopher.schulze@coxhealth.com

Principal Investigator:

Zachary Schmittling, M.D.

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Pauline Sirrell

603-650-4638 pauline.sirrell@hitchcock.org

Principal Investigator:

Bjoern Suckow, MD

Dartmouth Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Pauline Sirrell

603-650-4638 Sirrell@hitchcock.org

Principal Investigator:

Bjoern Suckow, M.D.

University at Buffalo, Research Foundation

Recruiting

Buffalo, New York, United States, 14203

Contacts

Dawn Holler

716-829-6115 dlh68@buffalo.edu

Principal Investigator:

Linda Harris, M.D.

Mission Hospital

Recruiting

Asheville, North Carolina, United States, 28801

Contacts

Lynne Hampton

828-213-5631 Lynne.Hampton@HCAhealthcare.com

Principal Investigator:

John Henretta, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Chris Burgess

919-843-1279 cdburges@email.unc.edu

Principal Investigator:

Mark Farber, M.D.

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Frank Benedetti

919-681-3445 frank.benedetti@duke.edu

Principal Investigator:

Chandler Long, MD

Duke Universtiy Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Frank Benedetti

901-428-3361 frank.benedetti@duke.edu

Principal Investigator:

Chandler Long, M.D.

Forsyth Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Phillip Moore

phillip.moore@novanthealth.org

Principal Investigator:

Phillip Moore, M.D.

Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Rob Paris

336-716-3296 rparis@wakehealth.edu

Principal Investigator:

Matthew Goldman, MD

Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Rob Paris

336-716-3296 robert.paris@advocatehealth.org

Principal Investigator:

Matthew Goldman, M.D.

University Hospitals - Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Terence Semenec

216-983-4724 Terence.Semenec@UHhospitals.org

Principal Investigator:

Jae-Sung Cho, M.D.

Portland VA Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Rachel Nelson

503-220-8262 Rachel.Nelson1@va.gov

Principal Investigator:

Enjae Jung, MD

Portland VA Health Care System

Recruiting

Portland, Oregon, United States, 97239

Contacts

Rachel Nelson

503-220-8262 Rachel.Nelson1@va.gov

Principal Investigator:

Enjae Jung, M.D.

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Carolina Reyes

215-662-4000 carolina.reyes1@Pennmedicine.upenn.edu

Principal Investigator:

Grace Wang, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Carolina Reyes

215-615-8036 Carolina.Reyes1@Pennmedicine.upenn.edu

Principal Investigator:

Grace Wang, M.D.

Prisma Health-Upstate

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Nikita Kasinger

864-454-2818 Nikita.Kasinger@PrismaHealth.org

Principal Investigator:

Sagar Gandhi, MD

Prisma Health-Upstate

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Nikita Kasinger

864-454-2818 Nikita.Kasinger@PrismaHealth.org

Principal Investigator:

Sagar Gandhi, M.D.

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Mirza Baig

949-874-5383 mirza.baig@utsouthwestern.edu

Principal Investigator:

Shadman Baig, M.D.

HCA Healthcare Research Institute/Columbia Medical Center of Plano

Recruiting

Plano, Texas, United States, 75075

Contacts

Pauline Matheri

469-659-2407 pauline.matheri@hcahealthcare.com

Principal Investigator:

Edic Stephanian, M.D.

Baylor Scott and White

Recruiting

Plano, Texas, United States, 75093

Contacts

Saba Arianpour

469-814-4183 Saba.Arianpour@BSWHealth.org

Principal Investigator:

Dennis Gable, M.D.

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Lexi Maycock

801-507-4693 lexi.maycock@imail.org

Principal Investigator:

Evan Brownie, MD

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Lexi Maycock

801-507-4693 Lexi.Maycock@imail.org

Principal Investigator:

Evan Brownie, M.D.

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Julie Hales

801-587-1450 julie.hales@hsc.utah.edu

Principal Investigator:

Nathan Droz, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Julie Hales

801-587-1450 Julie.Hales@hsc.utah.edu

Principal Investigator:

Nathan Droz, M.D.

Inova Health Care Services

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Alma Khan

703-776-5912 Alma.Khan2@inova.org

Principal Investigator:

Kendal Endicott, M.D.

Sentara Heart Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Kara Wiggins

757-388-7511 kvwiggin@sentara.com

Principal Investigator:

Animesh Rathore, MD

Sentara Heart Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Kara Wiggins

757-388-7511 KVWIGGIN@sentara.com

Principal Investigator:

Animesh Rathore, M.D.

CAMC Health and Education and Research Institute, Inc

Recruiting

Charleston, West Virginia, United States, 25304

Contacts

Kaylea Hoffman

304-388-9889 kaylea.hoffman@vandaliahealth.org

Principal Investigator:

Ali Aburahma, M.D.

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Elizabeth Weseman

414-955-1810 eweseman@mcw.edu

Principal Investigator:

Peter Rossi, M.D.

More Information

Sponsor

W.L.Gore & Associates

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

Aneurysm
Aneurysm Repair
Endovascular
EVAR
Endoprosthesis
Aortic
Aortic Repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by W.L.Gore & Associates on 2026-02-05.