Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01883999|
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : August 3, 2016
Last Update Posted : November 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Common Iliac Artery Aneurysms Aorto-iliac Aneurysms||Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Completion Date :||June 2021|
Experimental: GORE® EXCLUDER® Iliac Branch Endoprosthesis
GORE® EXCLUDER® Iliac Branch Endoprosthesis
Device: GORE® EXCLUDER® Iliac Branch Endoprosthesis
- 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.
- 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.
- 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).
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
|United States, New York|
|Weill Cornell Medical Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Darren Schneider, MD||Weill Medical College of Cornell University|