Overview

This trial is active, not recruiting.

Condition coronary stenosis
Sponsor Medstar Research Institute
Start date October 2012
End date January 2015
Trial size 500 participants
Trial identifier NCT01794065, REWARDS PE

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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

Primary Outcomes

Measure
Stent length
time frame: 1 day

Secondary Outcomes

Measure
IVUS stent length
time frame: 1 day

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients, male or female, 18 years or older; - Patients with de-novo coronary lesions and slated to receive a Promus Element stent; - Patients who are slated to undergo IVUS after stent deployment during implantation procedure Exclusion Criteria: - Patients receiving more than one drug-eluting stent within the same lesion during implantation procedure; - Patients with in-stent restenosis; - Patients who had IVUS imaging attained with manual pullback.

Additional Information

Official title The Promus Element Rewards Study
Principal investigator Ron Waksman, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Medstar Research Institute.