Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
NCT ID: NCT02489539
Last Updated: 2025-08-13
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
175 participants
INTERVENTIONAL
2017-12-19
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
NCT00615069
GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
NCT00593814
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
NCT03728985
GORE® EXCLUDER® Endoprosthesis French Mandatory Registry
NCT02308839
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
NCT06218875
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Short Neck Substudy
Subjects 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.
GORE® EXCLUDER® Conformable AAA Endoprosthesis
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.
High Neck Angulation Substudy
Subjects 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.
GORE® EXCLUDER® Conformable AAA Endoprosthesis
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GORE® EXCLUDER® Conformable AAA Endoprosthesis
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Maximum diameter ≥50 mm
* Rapid growth (\>5 mm in a 6 month period)
* Non-ruptured AAA presenting with clinical symptoms
2. Adequate anatomy to receive the GORE® EXCLUDER® Conformable AAA Endoprosthesis, including:
* Adequate iliac / femoral access
* 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
3. An Informed Consent Form (ICF) signed by Subject
4. Male or infertile female
5. Able to comply with Protocol requirements including following-up
6. Life expectancy \> 2 years
7. Age ≥ 21 years
Exclusion Criteria
2. Known concomitant thoracic aortic aneurysm which requires surgical intervention
3. Renal insufficiency defined as creatinine \> 2.5 mg/dL or patient undergoing dialysis
4. New York Heart Association (NYHA) class IV
5. Aneurysmal, dissected, heavily calcified, or heavily thrombosed landing zone(s)
6. Severely tortuous or stenotic iliac and / or femoral arteries
7. Patient has body habitus or other medical condition which prevents adequate delineation of the aorta
8. Participating in another investigational device or drug study within 1 year of treatment
9. Systemic infection which may increase the risk of endovascular graft infection
10. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
11. Planned concomitant surgical procedure or major surgery within 30 days of treatment date
12. Known history of drug abuse
13. Known sensitivities or allergies to the device materials
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
W.L.Gore & Associates
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Rhee, MD
Role: PRINCIPAL_INVESTIGATOR
Maimonides Medical Center (US)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
Leland Stanford Junior University
Stanford, California, United States
River City Clinical Research
Jacksonville, Florida, United States
Baptist Cardiac and Vascular Institute
Miami, Florida, United States
Florida Hospital
Orlando, Florida, United States
Sarasota Vascular Specialists
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Vascular Surgical Associates, PC
Marietta, Georgia, United States
Loyola University - Chicago
Maywood, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
University of Iowa Hospitals & Clinic
Iowa City, Iowa, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health System
Grand Rapids, Michigan, United States
Essentia Institute of Rural Health
Duluth, Minnesota, United States
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Minneapolis Radiology and Vascular Research Foundation
Plymouth, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Washington University School of Medicine - St. Louis
St Louis, Missouri, United States
Mercy Research
St Louis, Missouri, United States
The Hitchcock Foundation
Lebanon, New Hampshire, United States
AHA Hospital Corp.
Morristown, New Jersey, United States
Maimonides Medical Center
Brooklyn, New York, United States
Research Foundation SUNY Buffalo
Buffalo, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States
NC Heart and Vascular Research, LLC
Raleigh, North Carolina, United States
Good Samaritan Hospital-Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health-Upstate
Greenville, South Carolina, United States
Sanford Clinic - Clinic Research
Sioux Falls, South Dakota, United States
North Central Heart Institute, Ltd.
Sioux Falls, South Dakota, United States
University of Tennessee
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Heart Institute/Baylor St. Luke's Medical Center
Houston, Texas, United States
The Methodist Hospital - Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Medical Group
Norfolk, Virginia, United States
Inova Cardiology-Fairfax
Virginia Beach, Virginia, United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, United States
University of Wisconsin System
Madison, Wisconsin, United States
Aurora Health Care, Metro Inc.
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AAA 13-03 (1)
Identifier Type: -
Identifier Source: org_study_id
NCT02489552
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.