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Completed

NCT Number: NCT01883999

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery aneurysms (CIAA) or aorto-iliac aneurysms (AIA).

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Key information

Conditions

Common Iliac Artery Aneurysms Aorto-iliac Aneurysms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medical Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Common iliac aneurysm with or without concomitant abdominal aortic aneurysm
  • Adequate native anatomy to receive the EXCLUDER® and Iliac Branch Endoprostheses
  • An Informed Consent Form signed by Subject or legally authorized representative
  • Male or infertile female
  • Able to comply with protocol requirements including following-up
  • Life expectancy > 2 years
  • Age > 21 years
  • Surgical candidate

Exclusion criteria

  • Mycotic or ruptured aneurysm
  • Known concomitant thoracic aortic aneurysm which requires intervention
  • American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
  • Renal insufficiency defined or patient undergoing dialysis
  • New York Heart Association (NYHA) Functional Classification class IV
  • Dissected, heavily calcified, or heavily thrombosed landing zone(s)
  • Tortuous or stenotic iliac and/or femoral arteries
  • Participating in another investigational device or drug study within 1 year of treatment
  • Systemic infection which may increase the risk of endovascular graft infection
  • Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome
  • Planned concomitant surgical procedure or major surgery within 30 days of treatment date
  • Known history of drug abuse
  • Known sensitivities or allergies to the device materials

Treatment and study plan

GORE® EXCLUDER® Iliac Branch Endoprosthesis

Device

Primary outcomes

  1. Freedom From Composite of the Following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to Open Surgical Repair

    Time frame: 30 days post-treatment

    Freedom from composite of the following: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Conversion to open surgical repair.

  2. Freedom From: Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) Due to Type I/III Endoleak or to Re-establish Patency Due to 60% Occlusion or Greater, or Complete Loss of Blood Flow in Leg of IBC or IIC

    Time frame: Through 6 month follow-up visit

    Freedom from all of the following:

    • Reintervention on Iliac Branch Component (IBC) or Internal Iliac Component (IIC) due to Type I/III endoleak as determined by Clinical Events Committee (CEC).
    • Complete loss of blood flow in leg of IBC or IIC as assessed by Core Laboratory
    • Reintervention on IBC or IIC to re-establish patency due to 60% occlusion or greater as determined by CEC.

Secondary outcomes

  1. Freedom From New Onset Buttock Claudication Arising From the Side of the Body Treated With the Iliac Branch Component (IBC) and Internal Iliac Component (IIC)

    Time frame: Through 6 month follow-up visit

    Freedom from new onset buttock claudication arising from the side of the body treated with the Iliac Branch Component (IBC) and Internal Iliac Component (IIC).

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Official study title

Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms

Important dates

Study start
2013
Primary completion
2016
Study completion
2021
First posted
Jun 21, 2013
Registry last updated
Nov 2, 2021

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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