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Aortic Aneurysm, AbdominalNCT02489539

Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

A study testing GORE® EXCLUDER® Conformable AAA Endoprosthesis in people with Aortic Aneurysm, Abdominal, run by W.L.Gore & Associates at 51 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Aortic Aneurysm, Abdominal
What is being tested?
GORE® EXCLUDER® Conformable AAA Endoprosthesis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
51 sitesUnited States
Study dates
19 Dec 2017to 31 Dec 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • AAA meeting any of the following criteria:
  • Maximum diameter ≥50 mm
  • Rapid growth (>5 mm in a 6 month period)
  • Non-ruptured AAA presenting with clinical symptoms
  • Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:
  • Adequate iliac / femoral access
Show all 16Show fewer
  • Infrarenal aortic neck diameter 16-32 mm
  • Infrarenal aortic neck length ≥10 mm
  • Aortic neck angle ≤ 90˚
  • Distal iliac artery seal zone ≥10 mm
  • Iliac artery diameter 8-25 mm
  • An Informed Consent Form (ICF) signed by Subject
  • Male or infertile female
  • Able to comply with Protocol requirements including following-up
  • Life expectancy > 2 years
  • Age ≥ 21 years

Who cannot join

  • Mycotic or ruptured aneurysm
  • Known concomitant thoracic aortic aneurysm which requires surgical intervention
  • Renal insufficiency defined as creatinine > 2.5 mg/dL or patient undergoing dialysis
  • New York Heart Association (NYHA) class IV
  • Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
  • Severely tortuous or stenotic iliac and / or femoral arteries
Show all 13Show fewer
  • Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
  • Participating in another investigational device or drug study within 1 year of treatment
  • Systemic infection which may increase the risk of endovascular graft infection
  • Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  • Planned concomitant surgical procedure or major surgery within 30 days of treatment date
  • Known history of drug abuse
  • Known sensitivities or allergies to the device materials

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

United States51 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Emory University

    Atlanta, Georgia, 30342

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Research Foundation SUNY Buffalo

    Buffalo, New York, 14203

  • Medical University of South Carolina

    Charleston, South Carolina, 29401

  • CAMC Health Education and Research Institute, Inc.

    Charleston, West Virginia, 25304

  • University of Virginia

    Charlottesville, Virginia, 22908

  • Good Samaritan Hospital-Cincinnati

    Cincinnati, Ohio, 45220

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Essentia Institute of Rural Health

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Spectrum Health System

    Grand Rapids, Michigan, 49546

  • Moses Cone Memorial Hospital

    Greensboro, North Carolina, 27405

  • Prisma Health-Upstate

    Greenville, South Carolina, 29615

  • Texas Heart Institute/Baylor St. Luke's Medical Center

    Houston, Texas, 77030

  • The Methodist Hospital - Houston

    Houston, Texas, 77030

  • University of Iowa Hospitals & Clinic

    Iowa City, Iowa, 52242

  • River City Clinical Research

    Jacksonville, Florida, 32207

  • University of Tennessee

    Knoxville, Tennessee, 37920

  • The Hitchcock Foundation

    Lebanon, New Hampshire, 03756

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin System

    Madison, Wisconsin, 57392

  • Vascular Surgical Associates, PC

    Marietta, Georgia, 30060

  • Loyola University - Chicago

    Maywood, Illinois, 60153

  • Baptist Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Aurora Health Care, Metro Inc.

    Milwaukee, Wisconsin, 53215

  • Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • AHA Hospital Corp.

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • Oklahoma Heart Hospital Research Foundation

    Oklahoma City, Oklahoma, 73120

  • Florida Hospital

    Orlando, Florida, 32803

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Minneapolis Radiology and Vascular Research Foundation

    Plymouth, Minnesota, 55441

  • Rhode Island Hospital

    Providence, Rhode Island, 02905

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Sarasota Vascular Specialists

    Sarasota, Florida, 34232

  • Sanford Clinic - Clinic Research

    Sioux Falls, South Dakota, 57105

  • North Central Heart Institute, Ltd.

    Sioux Falls, South Dakota, 57108

  • Southern Illinois University

    Springfield, Illinois, 62794

  • Washington University School of Medicine - St. Louis

    St Louis, Missouri, 33176

  • Mercy Research

    St Louis, Missouri, 63110

  • Leland Stanford Junior University

    Stanford, California, 94305

  • Staten Island University Hospital

    Staten Island, New York, 10305

  • Inova Cardiology-Fairfax

    Virginia Beach, Virginia, 22031

Other trials in United States

About this study

The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.

Read the detailed description

The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population is 175 subjects with 80 subjects assigned to the Short Neck Substudy and 95 subjects to the High Neck Angulation Substudy.

This clinical study will include up to fifty-six sites in the US. Each enrolled subject will undergo periodic follow-up evaluations involving physical exams and contrast-enhanced computed tomography (CT) scans at specific, protocol-defined intervals for a period of five years following the GORE® EXCLUDER® Conformable AAA Endoprosthesis implant. Each Substudy will be evaluated and reported independently from each other according to the Safety and Effectiveness Endpoints. No comparative analyses between these substudies are planned.

Being tested
GORE® EXCLUDER® Conformable AAA Endoprosthesis
Keywords
Aortic aneurysm, Abdominal aorta, Stent graft, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Medical subject headings
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Aneurysm, Vascular Diseases, Cardiovascular Diseases

What participants receive

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

  • GORE® EXCLUDER® Conformable AAA EndoprosthesisDevice

    Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.

Study groups in NCT02489539
Study groupRoleWhat they receive
Short Neck SubstudyExperimentalSubjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
Receives: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
High Neck Angulation SubstudyExperimentalSubjects with abdominal aortic aneurysms having infrarenal aortic neck angulation > 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
Receives: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

What is being measured

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

  1. Number of Subjects Free From Primary Safety Endpoint Event

    The primary safety endpoint event includes a composite of the following:

    • Death
    • Stroke
    • Myocardial Infarction
    • Bowel Ischemia
    • Paraplegia
    • Respiratory Failure
    • Renal Failure
    • Procedural Blood Loss > 1000 mL
    • Thromboembolic events (including limb occlusion and distal embolic events)

    Measured: 30 Days

  2. Number of Subjects With Device Treatment Success

    The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from:

    • Type I endoleak in the 12 month window
    • Type III endoleak in the 12 month window
    • Migration (10 mm or more) at the 12 month window (relative to post-operative baseline)
    • AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline)
    • AAA rupture through the 12 month window
    • Conversion to open repair through the 12 month window

    Measured: 12 Months

Secondary outcomes (24)

  1. Number of Subjects With Reintervention

    Defined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  2. Number of Subjects With Stent Fracture

    Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  3. Number of Subjects With Type II Endoleak

    Defined as an endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  4. Number of Subjects With Aneurysm-related Mortality

    Defined as a composite of the following: death within 30 days or in hospital from initial procedure, death due to rupture of the originally treated aneurysm and death within 30 days or in hospital following a procedure to treat the originally treated aneurysm. (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  5. Number of Subjects With Significant Index Procedure Blood Loss

    Defined as estimated blood loss recorded during the endovascular procedure > 1000 mL

    Measured: Procedure Day

  6. Number of Subjects With Type IV Endoleak

    Defined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  7. Median Hospital Stay

    Defined as time to discharge for initial procedural hospitalization

    Measured: Through initial hospital discharge

  8. Median Index Procedure Time

    Defined as time from first arterial access in the groin to the closure of the final access vessel

    Measured: Procedure Day

  9. Number of Subjects With Severe Stroke

    Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  10. Number of Subjects With Severe Myocardial Infarction

    Defined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  11. Number of Subjects With Severe Bowel Ischemia

    Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  12. Number of Subjects With Severe Paraplegia

    Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  13. Number of Subject Deaths

    Defined as death of any cause (all-cause mortality)

    Measured: 5 years

  14. Number of Subjects With Severe Renal Failure

    Defined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  15. Number of Subjects With Severe Respiratory Failure

    Defined as respiratory failure resulting in prolonged intubation (> 48 hours), tracheostomy, deterioration in pulmonary function, new onset O2 dependence, or fatal outcome (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  16. Number of Subjects With Thromboembolic Events (Including Limb Occlusion and Distal Embolic Events)

    Defined as ischemic events from tissues distal to the device implantation site (lower extremity, buttock, etc.) and that are a direct result of an occlusion within the device or sufficiently debilitating to necessitate bypass, open surgical repair, or limb amputation (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  17. Number of Subjects With Type I Endoleak

    Defined as endoleak arising from the proximal (Type IA) or distal (Type IB) sealing zone of the device perfusing the aneurysm. (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  18. Number of Subjects With Type III Endoleak

    Defined as endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  19. Number of Subjects With Migration

    Defined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  20. Median Procedural Blood Loss (mL)

    Median blood loss at index procedure

    Measured: Procedure Day

  21. Number of Subjects With AAA Enlargement ≥5 mm

    Defined as AAA enlargement ≥5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)

    Measured: 5 years

  22. Number of Subjects With Abdominal Aortic Aneurysm Rupture

    Defined as rupture in the treated segment of the aorta verified with direct observation or CT scan

    Measured: 5 years

  23. Number of Subjects With Conversion to Open Repair

    Defined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee)

    Measured: 5 years

  24. Technical Success

    Successful access and deployment of all required CEXC device components, comprised of all the following:

    • Successful access
    • Successful deployment of Device endoprostheses in the intended anatomical location
    • Successful removal of all device delivery catheters from the patient
    • Patent Device components on completion angiography
    • Absence of Type I or Type III endoleak on completion angiography
    • Successful access site closure

    Measured: Procedure Day

Timeline

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

  1. First posted3 Jul 2015 (estimated)
  2. Study start19 Dec 2017
  3. Primary completion25 May 2023
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
175 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489539
Sponsor's protocol ID
AAA 13-03 (1)
Status last verified
Dec 2024
First submitted
22 Jun 2015
Last updated
13 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Device and aneurysm status will be communicated to subject through standard of care evaluations. Core Lab data will not be available to subjects.

Publications

  • Suckow BD, Oderich GS, Almadani MW, Yamanouchi D, Pyun AJ, Moore E, Muck PE, Rhee RY. Five-year pivotal trial outcomes of the Gore Excluder conformable endoprosthesis implanted in abdominal aortic aneurysms with short non-angulated infrarenal seal zones. J Vasc Surg. 2025 Sep;82(3):793-801.e1. doi: 10.1016/j.jvs.2025.04.038. Epub 2025 Jun 4.

    PubMed 40464725

  • Yamanouchi D, Oderich GS, Han S, Long C, Muck P, Moore E, Matsumura JS, Rhee R; EXCC Investigators. Three-year outcomes of a US pivotal trial substudy for conformable endoprosthesis in >/=10 mm nonangulated neck anatomy. J Vasc Surg. 2025 Jan;81(1):105-115.e1. doi: 10.1016/j.jvs.2024.06.166. Epub 2024 Sep 19.

    PubMed 39306018

  • Rhee RY, Almadani MW, Yamanouchi D, Oderich GS, Han S, Moore E, Matsumura JS. Early results from the pivotal trial substudy of the GORE EXCLUDER conformable endoprosthesis in angulated necks. J Vasc Surg. 2025 Feb;81(2):342-350.e2. doi: 10.1016/j.jvs.2024.09.013. Epub 2024 Sep 17.

    PubMed 39299529

Questions about this trial

What is this clinical trial studying?

A study testing GORE® EXCLUDER® Conformable AAA Endoprosthesis in people with Aortic Aneurysm, Abdominal, run by W.L.Gore & Associates at 51 sites in United States.

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 16 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. 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?

Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Free From Primary Safety Endpoint Event (time frame: 30 Days). The study lists 2 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 NCT02489539, which also lists 3 linked publications.

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 13 Aug 2025.

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