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

NCT02489539 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: AAA 13-03 (1)
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 51

Brief 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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

Aortic aneurysm; Abdominal aorta; Stent graft; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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)

  30 Days

• 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

  12 Months

Secondary Outcomes (24)

• Number of Subjects With Reintervention

  5 years

• Number of Subjects With Stent Fracture

  5 years

• Number of Subjects With Type II Endoleak

  5 years

• Number of Subjects With Aneurysm-related Mortality

  5 years

• Number of Subjects With Significant Index Procedure Blood Loss

  Procedure Day

Study Arms (2)

Short Neck Substudy

EXPERIMENTAL

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.

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

High Neck Angulation Substudy

EXPERIMENTAL

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.

Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

Interventions

GORE® EXCLUDER® Conformable AAA Endoprosthesis DEVICE

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; Short Neck Substudy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (51)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Leland Stanford Junior University

Stanford, California, 94305, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Sarasota Vascular Specialists

Sarasota, Florida, 34232, United States

Location

Emory University

Atlanta, Georgia, 30342, United States

Location

Vascular Surgical Associates, PC

Marietta, Georgia, 30060, United States

Location

Loyola University - Chicago

Maywood, Illinois, 60153, United States

Location

Southern Illinois University

Springfield, Illinois, 62794, United States

Location

University of Iowa Hospitals & Clinic

Iowa City, Iowa, 52242, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health System

Grand Rapids, Michigan, 49546, United States

Location

Essentia Institute of Rural Health

Duluth, Minnesota, 55805, United States

Location

Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Minneapolis Radiology and Vascular Research Foundation

Plymouth, Minnesota, 55441, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine - St. Louis

St Louis, Missouri, 33176, United States

Location

Mercy Research

St Louis, Missouri, 63110, United States

Location

The Hitchcock Foundation

Lebanon, New Hampshire, 03756, United States

Location

AHA Hospital Corp.

Morristown, New Jersey, 07960, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Research Foundation SUNY Buffalo

Buffalo, New York, 14203, United States

Location

Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Moses Cone Memorial Hospital

Greensboro, North Carolina, 27405, United States

Location

NC Heart and Vascular Research, LLC

Raleigh, North Carolina, 27607, United States

Location

Good Samaritan Hospital-Cincinnati

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

Prisma Health-Upstate

Greenville, South Carolina, 29615, United States

Location

Sanford Clinic - Clinic Research

Sioux Falls, South Dakota, 57105, United States

Location

North Central Heart Institute, Ltd.

Sioux Falls, South Dakota, 57108, United States

Location

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

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

Houston, Texas, 77030, United States

Location

The Methodist Hospital - Houston

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Inova Cardiology-Fairfax

Virginia Beach, Virginia, 22031, United States

Location

CAMC Health Education and Research Institute, Inc.

Charleston, West Virginia, 25304, United States

Location

University of Wisconsin System

Madison, Wisconsin, 57392, United States

Location

Aurora Health Care, Metro Inc.

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Diseases

Results Point of Contact

• Title: Charee Robe
• Organization: W.L. Gore & Associates

crobe@wlgore.com

928-864-4048

Study Officials

• Robert Rhee, MD

  Maimonides Medical Center (US)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: July 3, 2015
• Study Start: December 19, 2017
• Primary Completion: May 25, 2023
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 13, 2025
• Results First Posted: April 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (51)