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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489539
Recruitment Status : Recruiting
First Posted : July 3, 2015
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Tracking Information
First Submitted Date  ICMJE June 22, 2015
First Posted Date  ICMJE July 3, 2015
Last Update Posted Date April 29, 2019
Actual Study Start Date  ICMJE December 19, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
  • Aneurysm-related mortality [ Time Frame: 12 Months ]
  • Stent fracture based on core lab analysis [ Time Frame: 12 Months ]
  • Reintervention [ Time Frame: 12 Months ]
  • Type II endoleak [ Time Frame: 12 Months ]
  • Type IV endoleak [ Time Frame: 12 Months ]
  • Index Procedure Blood Loss [ Time Frame: 12 Months ]
  • Index Procedure Time [ Time Frame: 12 Months ]
  • Length of Hospital Stay (initial hospitalization) [ Time Frame: 12 Months ]
  • Death [ Time Frame: 12 Months ]
  • Stroke [ Time Frame: 12 Months ]
  • Myocardial Infarction [ Time Frame: 12 Months ]
  • Bowel Ischemia [ Time Frame: 12 Months ]
  • Paraplegia [ Time Frame: 12 Months ]
  • Respiratory Failure [ Time Frame: 12 Months ]
  • Renal Failure [ Time Frame: 12 Months ]
  • Procedural Blood Loss > 1000 mL [ Time Frame: 12 Months ]
  • Thromboembolic events (including limb occlusion and distal embolic events) [ Time Frame: 12 Months ]
  • Type I endoleak [ Time Frame: 12 Months ]
  • Type III endoleak [ Time Frame: 12 Months ]
  • Migration (10 mm or more) [ Time Frame: 12 Months ]
  • AAA enlargement ≥5 mm with or without intervention [ Time Frame: 12 Months ]
  • AAA rupture [ Time Frame: 12 Months ]
  • Conversion to open repair [ Time Frame: 12 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Official Title  ICMJE Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Aneurysm, Abdominal
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
  • 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.
    Intervention: Device: GORE® EXCLUDER® Conformable AAA Endoprosthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
190
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2015)
80
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Asia Harris (623) 234-5668 asharris@wlgore.com
Contact: Rob Lloyd (928) 864-4052 rlloyd@wlgore.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02489539
Other Study ID Numbers  ICMJE AAA 13-03 (1)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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.
Responsible Party W.L.Gore & Associates
Study Sponsor  ICMJE W.L.Gore & Associates
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Rhee, MD Maimonides Medical Center (US)
PRS Account W.L.Gore & Associates
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP