AzTrials
AzTrials

AAA - Abdominal Aortic AneurysmNCT06218875

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

An observational study of AAA - Abdominal Aortic Aneurysm, run by W.L.Gore & Associates at 90 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AAA - Abdominal Aortic Aneurysm
How many people
2,000 participants
Where
90 sitesin 12 countries
Study dates
7 May 2024to 30 Sep 2042
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

90 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Karen Martin contact

928-864-2223

kgmartin@wlgore.com

A. Lekuti contact

928-864-3576

alekuti@wlgore.com

90 sites in 12 countries

United States56 sites, 56 recruiting

  • Mission Hospital

    Asheville, North Carolina, 28801

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

    John Henretta, MD

    Recruiting

  • VA Medical Center- Atlanta

    Atlanta, Georgia, 30033

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

    Olamide Alabi, M.D.

    Recruiting

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30322

    Sonya Mathewson, 404-274-2368, sbmathe@emory.edu

    James Chang, M.D.

    Recruiting

  • Augusta University Medical Center

    Augusta, Georgia, 30912

    Sally El-Shafey, 706-446-0303, SELSHAFEY@augusta.edu

    Gautam Agarwal, M.D.

    Recruiting

  • University of Maryland - Baltimore

    Baltimore, Maryland, 21201

    Kim Nordstrom, 410-706-3037, KNordstrom@som.umaryland.edu

    Shahab Toursavadhohi, M.D.

    Recruiting

  • Our Lady of the Lake Regional Medical Center

    Baton Rouge, Louisiana, 70808

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

    P. Michael Davis, M.D.

    Recruiting

  • McLaren Heatlh Care Corporation

    Bay City, Michigan, 48708

    Sara Vernon, 989-891-8189, sara.vernon@mclaren.org

    Nicolas Mouawad, M.D.

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Monica Goyal, 617-667-7000, mgoyal@bidmc.harvard.edu

    Marc Schermerhorn, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

    Fernando Moreno, 617-632-8374, fmoreno@bidmc.harvard.edu

    Monica Goyal, mgoyal@bidmc.harvard.edu

    Recruiting

  • University at Buffalo, Research Foundation

    Buffalo, New York, 14203

    Dawn Holler, 716-829-6115, dlh68@buffalo.edu

    Linda Harris, M.D.

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Chris Burgess, 919-843-1279, cdburges@email.unc.edu

    Mark Farber, M.D.

    Recruiting

  • CAMC Health and Education and Research Institute, Inc

    Charleston, West Virginia, 25304

    Kaylea Hoffman, 304-388-9889, kaylea.hoffman@vandaliahealth.org

    Ali Aburahma, M.D.

    Recruiting

  • University of Chicago Hospital

    Chicago, Illinois, 60637

    Trissa Babrowski, 312-774-1781, trissa.babrowski@uchospitals.edu

    Trissa Babrowski, M.D.

    Recruiting

  • University Hospitals - Cleveland Medical Center

    Cleveland, Ohio, 44106

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

    Jae-Sung Cho, M.D.

    Recruiting

  • University of Missouri

    Columbia, Missouri, 65212

    Hannah Sinek, 573-884-3226, as8bc@health.missouri.edu

    Todd Vogel, M.D.

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Mirza Baig, 949-874-5383, mirza.baig@utsouthwestern.edu

    Shadman Baig, M.D.

    Recruiting

  • Atlanta VA Medical Center

    Decatur, Georgia, 30033

    Elizabeth Tibus, 404-321-6111 ext. 206967, elizabeth.tibus@va.gov

    Olamide Alabi, MD

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Frank Benedetti, 919-681-3445, frank.benedetti@duke.edu

    Chandler Long, MD

    Recruiting

  • Duke Universtiy Medical Center

    Durham, North Carolina, 27710

    Frank Benedetti, 901-428-3361, frank.benedetti@duke.edu

    Chandler Long, M.D.

    Recruiting

  • Endeavor Health

    Evanston, Illinois, 60026

    Karen Hynes, 847-503-5137, khynes@northshore.org

    CJ Lee, M.D.

    Recruiting

  • Inova Health Care Services

    Falls Church, Virginia, 22042

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

    Kendal Endicott, M.D.

    Recruiting

  • Corewell Health Medical Group West

    Grand Rapids, Michigan, 49546

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

    Eanas Yassa, M.D.

    Recruiting

  • Prisma Health-Upstate

    Greenville, South Carolina, 29615

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

    Sagar Gandhi, MD

    Recruiting

  • Prisma Health-Upstate

    Greenville, South Carolina, 29615

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

    Sagar Gandhi, M.D.

    Recruiting

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46260

    Allyn Harker, 317-338-6161, allyn.harker@ascension.org

    Brent Marsden, M.D.

    Recruiting

  • University of California - Irvine

    Irvine, California, 92697

    Lizette Spiers, 714-456-5694, lspiers@hs.uci.edu

    Anthony Chau, M.D.

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Pauline Sirrell, 603-650-4638, pauline.sirrell@hitchcock.org

    Bjoern Suckow, MD

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

    Pauline Sirrell, 603-650-4638, Sirrell@hitchcock.org

    Bjoern Suckow, M.D.

    Recruiting

  • Central Arkansas Veteran's Healthcare System

    Little Rock, Arkansas, 72205

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

    Lauren Story-Hefta, M.D.

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

    Amarilis Bolanos, 323-442-5763, amarilis.bolanos@med.usc.edu

    Sukgu Han, MD

    Recruiting

  • University of Southern California

    Los Angeles, California, 90033

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

    Sukgu Han, M.D.

    Recruiting

  • University of Louisville

    Louisville, Kentucky, 40202

    Leslie Haysley, 502-852-2801, leslie.haysley@louisville.edu

    Amit Dwivedi, M.D.

    Recruiting

  • Mount Sinai Vascular Institute

    Miami Beach, Florida, 33140

    Eduardo Palmero, Eduardo.PalmeroSau@msmc.com

    Michael Ayad, M.D.

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Elizabeth Weseman, 414-955-1810, eweseman@mcw.edu

    Peter Rossi, M.D.

    Recruiting

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

    Sara Behmanesh, 612-863-6287, sara.behmanesh@allina.com

    Elliot Stephenson, M.D.

    Recruiting

  • Intermountain Health

    Murray, Utah, 84107

    Lexi Maycock, 801-507-4693, lexi.maycock@imail.org

    Evan Brownie, MD

    Recruiting

  • Intermountain Health

    Murray, Utah, 84107

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

    Evan Brownie, M.D.

    Recruiting

  • Sentara Heart Hospital

    Norfolk, Virginia, 23507

    Kara Wiggins, 757-388-7511, kvwiggin@sentara.com

    Animesh Rathore, MD

    Recruiting

  • Sentara Heart Hospital

    Norfolk, Virginia, 23507

    Kara Wiggins, 757-388-7511, KVWIGGIN@sentara.com

    Animesh Rathore, M.D.

    Recruiting

  • Stanford University School of Medicine

    Palo Alto, California, 94304

    Suneetha Atluri, 650-561-5474, satluri2@stanford.edu

    Kenneth Tran, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Carolina Reyes, 215-662-4000, carolina.reyes1@Pennmedicine.upenn.edu

    Grace Wang, MD

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

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

    Grace Wang, M.D.

    Recruiting

  • HCA Healthcare Research Institute/Columbia Medical Center of Plano

    Plano, Texas, 75075

    Pauline Matheri, 469-659-2407, pauline.matheri@hcahealthcare.com

    Edic Stephanian, M.D.

    Recruiting

  • Baylor Scott and White

    Plano, Texas, 75093

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

    Dennis Gable, M.D.

    Recruiting

  • Portland VA Health Care System

    Portland, Oregon, 97239

    Rachel Nelson, 503-220-8262 ext. 57779, Rachel.Nelson1@va.gov

    Enjae Jung, MD

    Recruiting

  • Portland VA Health Care System

    Portland, Oregon, 97239

    Rachel Nelson, 503-220-8262 ext. 57779, Rachel.Nelson1@va.gov

    Enjae Jung, M.D.

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

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

    Jill Colglazier, M.D.

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Julie Hales, 801-587-1450, julie.hales@hsc.utah.edu

    Nathan Droz, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

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

    Nathan Droz, M.D.

    Recruiting

  • Cox Health

    Springfield, Missouri, 65807

    Christopher Schulze, 417-269-7114, christopher.schulze@coxhealth.com

    Zachary Schmittling, M.D.

    Recruiting

  • Stanford University School of Medicine

    Stanford, California, 94304

    Suneetha Atluri, 650-561-5474, satluri2@stanford.edu

    Kenneth Tran, M.D.

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Eric Johnson, 813-505-4787, eej11@usf.edu

    Dean Arnaoutakis, MD

    Recruiting

  • University of South Florida

    Tampa, Florida, 33606

    Eric Johnson, 610-573-4814, eej11@usf.edu

    Dean Arnaoutakis, M.D.

    Recruiting

  • Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

    Phillip Moore, phillip.moore@novanthealth.org

    Phillip Moore, M.D.

    Recruiting

  • Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Rob Paris, 336-716-3296, rparis@wakehealth.edu

    Matthew Goldman, MD

    Recruiting

  • Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

    Rob Paris, 336-716-3296, robert.paris@advocatehealth.org

    Matthew Goldman, M.D.

    Recruiting

Other trials in United States

Australia6 sites, 6 recruiting

  • Flinders Medical Centre (Vascular Unit)

    Bedford Park, South Australia

    Melanie Toomey, +08 82045445, melanie.tommey@sa.gov.au

    Richard Allan, richard.allan@sa.gov.au

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria

    Adi Zia, +61 477 775 309, A.Zia@alfred.org.au

    Thodur Vasudevan, M.D.

    Recruiting

  • John Hunter Hospital

    New Lambton Heights, New South Wales

    Natalie Lott, +61 439 405 000, Natalie.lott@health.nsw.gov.au

    Zoheb Williams, M.D.

    Not yet recruiting

  • Royal Perth Hospital

    Perth

    Jackie Wong, +08 9224 0226, jackie@bibombe.com

    Nishath Altaf, M.D.

    Recruiting

  • Gold Coast Hospital and Health Services

    Southport, Queensland

    Cheryl Rapier, +61 07 5687 8121, cheryl.rapier@health.qld.gov.au

    Venu Bhamidi, M.D.

    Recruiting

  • Royal Prince Alfred Hospital

    Sydney

    Beattie Beattie, +614 1538 7786, Lorna.Beattie@health.nsw.gov.au

    Jack Loa, M.D.

    Not yet recruiting

Other trials in Australia

Italy6 sites, 6 recruiting

  • Azienda Ospedaliero Universitaria delle Marche Ospedali Riuniti di Ancona

    Ancona

    Emanuele Gatta, +39 0715964411, emanuele.gatta@ospedaliriuniti.marche.it

    Emanuele Gatta

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico di Bari

    Bari

    Domenico Angiletta, +39 0805592006, domenico.angiletta@uniba.it

    Domenico Angiletta, MD

    Recruiting

  • Azienda Ospedaliero Universitaria Policlinico di Bari

    Bari

    Domenico Angiletta, Professor, +39 0805592006, domenico.angiletta@uniba.it

    Domenico Angiletta, M.D.

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia

    Antonio Bozzani, +39 0382 502940, a.bozzani@smatteo.pv.it

    Antonio Bozzani

    Recruiting

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

    Torino

    Fabio Verzini, +39 0116335100, fabio.verzini@unito.it

    Fabio Verzini

    Recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona

    Gian Franco Veraldi, +39 0458122050, chirurgia.vascolare@aovr.veneto.it

    Gian Franco Veraldi

    Recruiting

Other trials in Italy

United Kingdom6 sites, 6 recruiting

  • University Hospitals of Leicester NHS Trust

    Leicester

    Gregory McMahon, +44 116 2587768, gregory.mcmahon@uhl-tr.nhs.uk

    Gregory McMahon

    Recruiting

  • Countess of Chester Hospital NHS Foundation Trust

    Liverpool

    Leith Williams, +44 01244 365000, leith.williams@nhs.net

    Leith Williams, MD

    Recruiting

  • Countess of Chester Hospital NHS Foundation Trust

    Liverpool

    Leith Williams, Mr., +44 01244 365000, leith.williams@nhs.net

    Leith Williams, Mr.

    Recruiting

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

    London

    Colin Bicknell, +44 020 3312 6428, colin.bicknell@nhs.net

    Colin Bicknell

    Recruiting

  • St Thomas Hospital - Guys and St. Thomas' NHS

    London

    Said Abisi, +44 0207 1887188 ext. 53821, said.abisi@gstt.nhs.uk

    Said Abisi, MD

    Recruiting

  • St Thomas Hospital - Guys and St. Thomas' NHS

    London

    Said Abisi, M.D., +44 02071887188 ext. 53821/55898, said.abisi@gstt.nhs.uk

    Said Abisi, M.D.

    Recruiting

Other trials in United Kingdom

Finland4 sites, 4 recruiting

  • Helsinki University Hospital (HYKS III)

    Helsinki

    Pekka Aho, M.D., +358 50 4272 412, Pekka.Aho@hus.fi

    Pekka Aho, MD

    Recruiting

  • Helsinki University Hospital (HYKS III)

    Helsinki

    Pekka Aho, +358 50 4272 412, Pekka.Aho@hus.fi

    Pekka Aho

    Recruiting

  • Wellbeing Services County of Pirkanmaa Tampere University Hospital

    Tampere

    Velipekka Suominen, +35 8 03 3116 5049, velipekka.suominen@pirha.fi

    Velipekka Suominen, M.D.

    Recruiting

  • Wellbeing Services County of Pirkanmaa

    Tampere

    Velipekka Suominen, +35 8 03 3116 5049, velipekka.suominen@pirha.fi

    Velipekka Suominen, MD

    Recruiting

Other trials in Finland

Netherlands3 sites, 3 recruiting

  • Amsterdam UMC Research BV

    Amsterdam

    Kak Khee Yeung, +31 622612862, k.yeung@amsterdamumc.nl

    Kak Khee Yeung

    Recruiting

  • Stichting Elisabeth-Tweesteden Ziekenhuis

    Tilburg

    Jan Heyligers, +31-13-2212132, j.heyligers@etz.nl

    Jan Heyligers

    Recruiting

  • VieCuri Medical Center

    Venlo

    Jan-Willem Elshof, 0031-6-41268836, jelshof@viecuri.nl

    Jan-Willem Elshof

    Recruiting

Other trials in Netherlands

New Zealand2 sites, 2 recruiting

  • Auckland District Health Board Charitable Trust

    Auckland

    Cindy Corne, +64 9 307 4949 ext. 21505, cornec@adhb.govt.nz

    Anastasia Dean, M.D.

    Recruiting

  • Clinical Trials New Zealand Limited - Waikato Hospital

    Hamilton, Waikato Region

    Lenka Feisst, +64 78430105, lenka@clinicaltrialsnz.com

    Manar Khashram, M.D.

    Recruiting

Other trials in New Zealand

Spain2 sites, 2 recruiting

  • Hospital De La Santa Creu i Sant Pau

    Barcelona

    Jaume Felix Dilme, 0034 93 553 70 99, jdilme@santpau.cat

    Jaume Dilme

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Lucas Fuentes, M.D., +34955 012 342, lucasmengibar@gmail.com

    Lucas Fuentes, M.D.

    Recruiting

Other trials in Spain

Sweden2 sites, 2 recruiting

  • Karolinska University Hospital

    Stockholm

    Carl Wahlgren, +46 08 123 744 55, carl.wahlgren@regionstockholm.se

    Carl Wahlgren, MD

    Recruiting

  • Karolinska University Hospital

    Stockholm

    Carl Magnus Wahlgren, Professor, +46 08 123 744 55, carl.wahlgren@regionstockholm.se

    Carl Magnus Wahlgren, M.D.

    Recruiting

Other trials in Sweden

Austria1 site, 1 recruiting

  • Medizinische Universitat Wien

    Vienna

    Florian Wolf, +43 1 40400 58900, florian.wolf@meduniwien.ac.at

    Florian Wolf

    Recruiting

Other trials in Austria

Israel1 site, 1 recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Basheer Sheikh-Yousif, M.D., +972 36973641, basheersy@tlvmc.gov.il

    Basheer Sheikh-Yousif, M.D.

    Recruiting

Other trials in Israel

Poland1 site, 1 recruiting

  • Uniwersytecki Szpital Kliniczny NR 1 W Lublinie

    Lublin

    Piotr Terlecki, +601 381 156, piotr.terlecki@umlub.pl

    Piotr Terlecki, Professor

    Not yet recruiting

Other trials in Poland

About this study

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

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.

Read the 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.

Keywords
Aneurysm, Aneurysm Repair, Endovascular, EVAR, Endoprosthesis, Aortic, Aortic Repair
Medical subject headings
Aortic Aneurysm, Abdominal, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06218875
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Deployment Technical Success

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

    Measured: Time of Surgery

  2. 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

    Measured: Day 30 through Year 10

  3. 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

    Measured: Time of Surgery through Year 10

  4. 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

    Measured: Time of Surgery through Year 10

  5. Endoleaks

    Perfusion of a treated lesion identified through imaging analysis

    Measured: Time of Surgery through Year 10

  6. 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.

    Measured: Time of Surgery through Year 10

  7. 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.

    Measured: Time of Surgery through Year 10

  8. 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

    Measured: Time of Surgery through Day 30

  9. Renal function deterioration

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

    Measured: Time of Surgery through Year 10

  10. Device integrity events

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

    Measured: Time of Surgery through Year 10

  11. Reintervention

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

    Measured: Time of Surgery through Year 10

Secondary outcomes (2)

  1. Characterization of remote data collection to supplement follow-up activities

    An exploratory description intended to assign significance to an increasingly used method of participant engagement to assess utilization, frequency by time, outcomes, contribution to total follow-up, need for elevation of care

    Measured: Time of Surgery through Year 10

  2. New onset buttock claudication / erectile dysfunction

    Patient reported

    Measured: Time of Surgery through Year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start7 May 2024
  3. Primary completion30 Sep 2042 (estimated)
  4. Study completion30 Sep 2042 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218875
Sponsor's protocol ID
TGR 23-02AA
Status last verified
Feb 2026
First submitted
11 Jan 2024
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data to be shared will be pseudo-anonymized with subject names and birthdates removed, but information such as procedure date will not.

Publications

  • Yamanouchi D, Khashram M, Gable D, Milner R, Yeung KK, Resch TA, Bockler D, Delaney C, Azizzadeh A, Shimamura K, Qasabian R, Han S, Feito Y, Trimarchi S. Real-world data on aortic endografts: Gore Together aortic registry protocol. Front Cardiovasc Med. 2026 Aug 28;13:1803528. doi: 10.3389/fcvm.2026.1803528. eCollection 2026.

    PubMed 42729155

Questions about this trial

What is this clinical trial studying?

An observational study of AAA - Abdominal Aortic Aneurysm, run by W.L.Gore & Associates at 90 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States, Australia, Italy, United Kingdom, Finland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karen Martin (928-864-2223, kgmartin@wlgore.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Deployment Technical Success (time frame: Time of Surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06218875, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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Clinical Trial NCT06218875 | AzTrials