VISIBILITY™ 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: NCT01402700|
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : September 16, 2015
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Claudication||Device: Visi-Pro™ Balloon Expandable Stent System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Visi-Pro™ Balloon Expandable Iliac Study (VISIBILITY™ Iliac)|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2015|
Experimental: Visi-Pro™ Balloon Expandable Stent System
The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Device: Visi-Pro™ Balloon Expandable Stent System
Implantation of one or more study devices in the common and/or external iliac artery.
- Major Adverse Event Rate at 9 Months [ Time Frame: 9 months ]The Major Adverse Event rate at 9 months is defined as a composite of periprocedural death, in-hospital MI, clinically-driven target lesion revascularization and amputation of the treated limb through 9 months postprocedure.
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): NCT01402700
|United States, New Jersey|
|Holy Name Medical Center|
|Teaneck, New Jersey, United States|
|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|