Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
Purpose
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.
Condition
- AAA - Abdominal Aortic Aneurysm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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 |
Recruiting Locations
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
University of California - Irvine
Irvine, California 92697
Irvine, California 92697
University of Southern California
Los Angeles, California 90033
Los Angeles, California 90033
University of Southern California
Los Angeles, California 90033
Los Angeles, California 90033
Stanford University School of Medicine
Palo Alto, California 94304
Palo Alto, California 94304
Stanford University School of Medicine
Stanford, California 94304
Stanford, California 94304
Mount Sinai Vascular Institute
Miami Beach, Florida 33140
Miami Beach, Florida 33140
VA Medical Center- Atlanta
Atlanta, Georgia 30033
Atlanta, Georgia 30033
Emory Saint Joseph's Hospital
Atlanta, Georgia 30322
Atlanta, Georgia 30322
Augusta University Medical Center
Augusta, Georgia 30912
Augusta, Georgia 30912
Atlanta VA Medical Center
Decatur, Georgia 30033
Decatur, Georgia 30033
University of Chicago Hospital
Chicago, Illinois 60637
Chicago, Illinois 60637
St. Vincent Medical Group, Inc.
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
University of Louisville
Louisville, Kentucky 40202
Louisville, Kentucky 40202
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana 70808
Baton Rouge, Louisiana 70808
University of Maryland - Baltimore
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
McLaren Heatlh Care Corporation
Bay City, Michigan 48708
Bay City, Michigan 48708
Corewell Health Medical Group West
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
University of Missouri
Columbia, Missouri 65212
Columbia, Missouri 65212
Cox Health
Springfield, Missouri 65807
Springfield, Missouri 65807
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
Lebanon, New Hampshire 03766
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03766
Lebanon, New Hampshire 03766
University at Buffalo, Research Foundation
Buffalo, New York 14203
Buffalo, New York 14203
Mission Hospital
Asheville, North Carolina 28801
Asheville, North Carolina 28801
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Duke Universtiy Medical Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Forsyth Medical Center
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
Wake Forest Baptist
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Wake Forest Baptist
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
University Hospitals - Cleveland Medical Center
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Portland VA Health Care System
Portland, Oregon 97239
Portland, Oregon 97239
Portland VA Health Care System
Portland, Oregon 97239
Portland, Oregon 97239
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Prisma Health-Upstate
Greenville, South Carolina 29615
Greenville, South Carolina 29615
Prisma Health-Upstate
Greenville, South Carolina 29615
Greenville, South Carolina 29615
UT Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
HCA Healthcare Research Institute/Columbia Medical Center of Plano
Plano, Texas 75075
Plano, Texas 75075
Baylor Scott and White
Plano, Texas 75093
Plano, Texas 75093
University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Inova Health Care Services
Falls Church, Virginia 22042
Falls Church, Virginia 22042
Sentara Heart Hospital
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Sentara Heart Hospital
Norfolk, Virginia 23507
Norfolk, Virginia 23507
CAMC Health and Education and Research Institute, Inc
Charleston, West Virginia 25304
Charleston, West Virginia 25304
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT06218875
- Status
- Recruiting
- Sponsor
- W.L.Gore & Associates
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.