The Promus Element Rewards Study
This study is being done to study stent deformation on persons with de novo coronary lesions to determine how much deformation takes place and how often. The information gathered from the group that receives the Promus element stent will be compared to other groups that receive other contemporary drug eluting stents.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Promus Element Rewards Study|
- Stent length [ Time Frame: 1 day ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|