DURABILITY™ Iliac Study
|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: NCT01400919|
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : June 24, 2015
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Claudication||Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Protege® EverFlex™ and GPS™ Self-Expanding Iliac Study (DURABILITY™ Iliac)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||January 2016|
Experimental: Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Implantation of one or more study devices in the common and/or external iliac artery.
- Major Adverse Event Rate [ Time Frame: 9 months ]
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): NCT01400919
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|Principal Investigator:||Peter L. Faries, M.D.||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||John H. Rundback, M.D.||Holy Name Medical Center|