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

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ClinicalTrials.gov Identifier: NCT02489539
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Actual Study Start Date : December 19, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : December 2024

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety as measured by a composite of Adverse Events [ Time Frame: 30 Days ]

    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)

  2. Effectiveness as measured by a composite of Adverse Events [ Time Frame: 12 Months ]

    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 :
  1. Aneurysm-related mortality [ Time Frame: 12 Months ]
  2. Stent fracture based on core lab analysis [ Time Frame: 12 Months ]
  3. Reintervention [ Time Frame: 12 Months ]
  4. Type II endoleak [ Time Frame: 12 Months ]
  5. Type IV endoleak [ Time Frame: 12 Months ]
  6. Index Procedure Blood Loss [ Time Frame: 12 Months ]
  7. Index Procedure Time [ Time Frame: 12 Months ]
  8. Length of Hospital Stay (initial hospitalization) [ Time Frame: 12 Months ]
  9. Death [ Time Frame: 12 Months ]
  10. Stroke [ Time Frame: 12 Months ]
  11. Myocardial Infarction [ Time Frame: 12 Months ]
  12. Bowel Ischemia [ Time Frame: 12 Months ]
  13. Paraplegia [ Time Frame: 12 Months ]
  14. Respiratory Failure [ Time Frame: 12 Months ]
  15. Renal Failure [ Time Frame: 12 Months ]
  16. Procedural Blood Loss > 1000 mL [ Time Frame: 12 Months ]
  17. Thromboembolic events (including limb occlusion and distal embolic events) [ Time Frame: 12 Months ]
  18. Type I endoleak [ Time Frame: 12 Months ]
  19. Type III endoleak [ Time Frame: 12 Months ]
  20. Migration (10 mm or more) [ Time Frame: 12 Months ]
  21. AAA enlargement ≥5 mm with or without intervention [ Time Frame: 12 Months ]
  22. AAA rupture [ Time Frame: 12 Months ]
  23. Conversion to open repair [ Time Frame: 12 Months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489539


Contacts
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Contact: Asia Harris (623) 234-5668 asharris@wlgore.com
Contact: Rob Lloyd (928) 864-4052 rlloyd@wlgore.com

Locations
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Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Robert Rhee, MD Maimonides Medical Center (US)
More Information
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT02489539    
Obsolete Identifiers: NCT02489552
Other Study ID Numbers: AAA 13-03 (1)
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by W.L.Gore & Associates:
Aortic aneurysm
Abdominal aorta
Stent graft
 Aneurysm
Vascular Diseases
Cardiovascular Diseases
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases