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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis

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.

• Study Type: Interventional
• Enrollment (Actual): 175
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Stanford, California, United States, 94305
      • Leland Stanford Junior University
  • Florida
    • Jacksonville, Florida, United States, 32207
      • River City Clinical Research
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Sarasota, Florida, United States, 34232
      • Sarasota Vascular Specialists
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Emory University
    • Marietta, Georgia, United States, 30060
      • Vascular Surgical Associates, PC
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University - Chicago
    • Springfield, Illinois, United States, 62794
      • Southern Illinois University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals & Clinic
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Spectrum Health System
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Institute of Rural Health
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation - Abbott Northwestern Hospital
    • Plymouth, Minnesota, United States, 55441
      • Minneapolis Radiology and Vascular Research Foundation
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 33176
      • Washington University School of Medicine - St. Louis
    • Saint Louis, Missouri, United States, 63110
      • Mercy Research
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • The Hitchcock Foundation
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • AHA Hospital Corp.
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Buffalo, New York, United States, 14203
      • Research Foundation SUNY Buffalo
    • Staten Island, New York, United States, 10305
      • Staten Island University Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greensboro, North Carolina, United States, 27405
      • Moses Cone Memorial Hospital
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital-Cincinnati
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital Research Foundation
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health-Upstate
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart Institute, Ltd.
    • Sioux Falls, South Dakota, United States, 57105
      • Sanford Clinic - Clinic Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Heart Institute/Baylor St. Luke's Medical Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital - Houston
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group
    • Virginia Beach, Virginia, United States, 22031
      • Inova Cardiology-Fairfax
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • CAMC Health Education and Research Institute, Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 57392
      • University of Wisconsin System
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care, Metro Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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

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:

1. Mycotic or ruptured aneurysm
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	5 years
Number of Subjects With Stent Fracture	Defined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)	5 years
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)	5 years
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)	5 years
Number of Subjects With Significant Index Procedure Blood Loss	Defined as estimated blood loss recorded during the endovascular procedure > 1000 mL	Procedure Day
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)	5 years
Median Hospital Stay	Defined as time to discharge for initial procedural hospitalization	Through initial hospital discharge
Median Index Procedure Time	Defined as time from first arterial access in the groin to the closure of the final access vessel	Procedure Day
Number of Subjects With Severe Stroke	Defined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)	5 years
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)	5 years
Number of Subjects With Severe Bowel Ischemia	Defined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)	5 years
Number of Subjects With Severe Paraplegia	Paraplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)	5 years
Number of Subject Deaths	Defined as death of any cause (all-cause mortality)	5 years
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)	5 years
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)	5 years
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)	5 years
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)	5 years
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)	5 years
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)	5 years
Median Procedural Blood Loss (mL)	Median blood loss at index procedure	Procedure Day
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)	5 years
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	5 years
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)	5 years
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	Procedure Day

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Robert Rhee, MD, Maimonides Medical Center (US)

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2017
• Primary Completion (Actual): May 25, 2023
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimated): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Vascular Diseases; Cardiovascular Diseases; Aneurysm; Aortic aneurysm; Abdominal aorta; Stent graft
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: AAA 13-03 (1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No