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Completed

NCT Number: NCT00593814

GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms

The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
  • Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
  • Access vessel able to receive 18 French introducer sheath
  • Life expectancy > 2 years
  • Appropriate candidate for endovascular repair
  • Ability to comply with protocol requirements including follow-up
  • 21 years of age or older, male or infertile female**

Exclusion criteria

  • Mycotic or ruptured aneurysm
  • Participating in another investigational device or drug study within one year
  • Documented history of drug abuse within six months
  • Myocardial infarction or cerebral vascular accident within six weeks
  • Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
  • Iliac anatomy that would require occlusion of both internal iliac arteries
  • Planned occlusion or reimplantation of significant mesenteric or renal arteries
  • Planned concomitant surgical procedure or previous major surgery within 30 days
  • Previous prosthesis placement in the aorta or iliac arteries
  • Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

Treatment and study plan

GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability

Device

Implant

Primary outcomes

  1. Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure

    Time frame: 2 years

Secondary outcomes

  1. Number of Subjects With Device Efficacy Events

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 15, 2008
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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