The Promus Element Rewards 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: NCT01794065|
Recruitment Status : Unknown
Verified August 2014 by Medstar Health Research Institute.
Recruitment status was: Active, not recruiting
First Posted : February 18, 2013
Last Update Posted : August 11, 2014
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||The Promus Element Rewards Study|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||January 2015|
100 patients who have received a Cypher stent during their coronary intervention
100 patients who have received a Taxus Express stent during their coronary intervention
100 patients who have received an Endeavor stent during their coronary intervention
100 patients who have received a Promus/Xience V stent during their coronary intervention
100 patients who have received a Taxus Element stent during their coronary intervention
- Stent length [ Time Frame: 1 day ]The primary endpoint of this study will be to assess the overall change in stent length post deployment by intravascualar ultrasound (IVUS) between the 5 stent groups.
- IVUS stent length [ Time Frame: 1 day ]The secondary endpoints of this analysis will be to detect the occurrence of a 10% change in stent length by IVUS as compared to the labeled stent length.
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): NCT01794065
|United States, District of Columbia|
|Medstar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Ron Waksman, MD||Medstar Washington Hospital Center|