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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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.


Sponsor: W.L.Gore & Associates

Current Primary Outcome:

  • 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: W.L.Gore & Associates

Dates:
Date Received: June 22, 2015
Date Started: October 2017
Date Completion: October 2024
Last Updated: April 26, 2017
Last Verified: April 2017