Back to resultsAssessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Primary Purpose
Aortic Aneurysm, Abdominal
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GORE® EXCLUDER® Conformable AAA Endoprosthesis
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Aneurysm, Abdominal focused on measuring Aortic aneurysm, Abdominal aorta, Stent graft, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Eligibility Criteria
Inclusion Criteria:
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
- Age ≥ 21 years
Exclusion Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham
- Mayo Clinic Arizona
- University of Southern California
- Leland Stanford Junior University
- River City Clinical Research
- Baptist Cardiac and Vascular Institute
- Sarasota Vascular Specialists
- Emory University
- Loyola University - Chicago
- Southern Illinois University
- University of Iowa Hospitals & Clinic
- Ochsner Clinic Foundation
- University of Michigan
- Spectrum Health System
- Essentia Institute of Rural Health
- Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
- Minneapolis Radiology and Vascular Research Foundation
- Mayo Clinic - Rochester
- Washington University School of Medicine - St. Louis
- Mercy Research
- The Hitchcock Foundation
- AHA Hospital Corp.
- Maimonides Medical Center
- Research Foundation SUNY Buffalo
- Mission Hospital
- Duke University Medical Center
- Moses Cone Memorial Hospital
- NC Heart and Vascular Research, LLC
- Good Samaritan Hospital-Cincinnati
- Cleveland Clinic Foundation
- Ohio Health Research Institute
- Oklahoma Heart Hospital Research Foundation
- University of Pittsburgh Medical Center
- Rhode Island Hospital
- Medical University of South Carolina
- Prisma Health-Upstate
- North Central Heart Institute, Ltd.
- University of Tennessee
- Vanderbilt University Medical Center
- The Methodist Hospital - Houston
- University of Virginia
- Sentara Medical Group
- CAMC Health Education and Research Institute, Inc.
- University of Wisconsin System
- Aurora Health Care, Metro Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Short Neck Substudy
High Neck Angulation Substudy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Safety as measured by a composite of Adverse Events
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)
Effectiveness as measured by a composite of Adverse Events
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) between the one month and at the 12 month window
AAA enlargement ≥5 mm with or without intervention between the one month and the 12 month window
AAA rupture through the 12 month window
Conversion to open repair through the 12 month window
Secondary Outcome Measures
Reintervention
Effectiveness as measured by a composite of Adverse Events
Stent fracture based on core lab analysis
Effectiveness as measured by a composite of Adverse Events
Type II endoleak
Effectiveness as measured by a composite of Adverse Events
Aneurysm-related mortality
Effectiveness as measured by a composite of Adverse Events
Index Procedure Blood Loss
Effectiveness as measured by a composite of Adverse Events
Type IV endoleak
Effectiveness as measured by a composite of Adverse Events
Length of Hospital Stay (initial hospitalization)
Effectiveness as measured by a composite of Adverse Events
Index Procedure Time
Effectiveness as measured by a composite of Adverse Events
Stroke
Effectiveness as measured by a composite of Adverse Events
Myocardial Infarction
Effectiveness as measured by a composite of Adverse Events
Bowel Ischemia
Effectiveness as measured by a composite of Adverse Events
Paraplegia
Effectiveness as measured by a composite of Adverse Events
Death
Effectiveness as measured by a composite of Adverse Events
Renal Failure
Effectiveness as measured by a composite of Adverse Events
Respiratory Failure
Effectiveness as measured by a composite of Adverse Events
Thromboembolic events (including limb occlusion and distal embolic events)
Effectiveness as measured by a composite of Adverse Events
Type I endoleak
Effectiveness as measured by a composite of Adverse Events
Type III endoleak
Effectiveness as measured by a composite of Adverse Events
Migration (10 mm or more)
Effectiveness as measured by a composite of Adverse Events
Procedural Blood Loss > 1000 mL
Effectiveness as measured by a composite of Adverse Events
AAA enlargement ≥5 mm with or without intervention
Effectiveness as measured by a composite of Adverse Events
AAA rupture
Effectiveness as measured by a composite of Adverse Events
Conversion to open repair
Effectiveness as measured by a composite of Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02489539
Brief Title
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Official Title
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 19, 2017 (Actual)
Primary Completion Date
August 15, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The study design is a prospective, nonrandomized, international, multicenter study comprised of two parallel substudies. The total subject population will be 190 subjects with 80 subjects assigned to the Short Neck Substudy and 110 subjects to the High Neck Angulation Substudy.
This clinical study will include 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
Aortic aneurysm, Abdominal aorta, Stent graft, Aneurysm, Vascular Diseases, Cardiovascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short Neck Substudy
Arm Type
Experimental
Arm Description
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.
Arm Title
High Neck Angulation Substudy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
GORE® EXCLUDER® Conformable AAA Endoprosthesis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety as measured by a composite of Adverse Events
Description
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)
Time Frame
30 Days
Title
Effectiveness as measured by a composite of Adverse Events
Description
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) between the one month and at the 12 month window
AAA enlargement ≥5 mm with or without intervention between the one month and the 12 month window
AAA rupture through the 12 month window
Conversion to open repair through the 12 month window
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Reintervention
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Stent fracture based on core lab analysis
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Type II endoleak
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Aneurysm-related mortality
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Index Procedure Blood Loss
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Type IV endoleak
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Length of Hospital Stay (initial hospitalization)
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Index Procedure Time
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Stroke
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Myocardial Infarction
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Bowel Ischemia
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Paraplegia
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Death
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Renal Failure
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Respiratory Failure
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Thromboembolic events (including limb occlusion and distal embolic events)
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Type I endoleak
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Type III endoleak
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Migration (10 mm or more)
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Procedural Blood Loss > 1000 mL
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
AAA enlargement ≥5 mm with or without intervention
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
AAA rupture
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
Title
Conversion to open repair
Description
Effectiveness as measured by a composite of Adverse Events
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Age ≥ 21 years
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Rhee, MD
Organizational Affiliation
Maimonides Medical Center (US)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Leland Stanford Junior University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
River City Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Baptist Cardiac and Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Sarasota Vascular Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Loyola University - Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
University of Iowa Hospitals & Clinic
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health System
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Essentia Institute of Rural Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Minneapolis Radiology and Vascular Research Foundation
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Mayo Clinic - Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
33176
Country
United States
Facility Name
Mercy Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Hitchcock Foundation
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
AHA Hospital Corp.
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Research Foundation SUNY Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Moses Cone Memorial Hospital
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
NC Heart and Vascular Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Good Samaritan Hospital-Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Oklahoma Heart Hospital Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
Prisma Health-Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
North Central Heart Institute, Ltd.
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
University of Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
The Methodist Hospital - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
CAMC Health Education and Research Institute, Inc.
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
University of Wisconsin System
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
57392
Country
United States
Facility Name
Aurora Health Care, Metro Inc.
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Device and aneurysm status will be communicated to subject through standard of care evaluations. Core Lab data will not be available to subjects.
Learn more about this trial
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
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