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Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis

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ClinicalTrials.gov Identifier: NCT01883999
Recruitment Status : Active, not recruiting
First Posted : June 21, 2013
Results First Posted : August 3, 2016
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Common Iliac Artery Aneurysms Aorto-iliac Aneurysms Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-iliac Aneurysms
Actual Study Start Date : October 2013
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: GORE® EXCLUDER® Iliac Branch Endoprosthesis
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis



Primary Outcome Measures :
  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 Outcome Measures :
  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).



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

Exclusion Criteria:

  1. Mycotic or ruptured aneurysm
  2. Known concomitant thoracic aortic aneurysm which requires intervention
  3. American Society of Anesthesiologists (ASA) Physical Status classification system class V (moribund patient not expected to live 24 hours with or without operation)
  4. Renal insufficiency defined or patient undergoing dialysis
  5. New York Heart Association (NYHA) Functional Classification class IV
  6. Dissected, heavily calcified, or heavily thrombosed landing zone(s)
  7. Tortuous or stenotic iliac and/or femoral arteries
  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

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): NCT01883999


Locations
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United States, New York
Weill Cornell Medical Center
New York, New York, United States, 10065
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
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Principal Investigator: Darren Schneider, MD Weill Medical College of Cornell University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01883999     History of Changes
Other Study ID Numbers: IBE 12-04
First Posted: June 21, 2013    Key Record Dates
Results First Posted: August 3, 2016
Last Update Posted: December 4, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases