The Promus Element Rewards Study

Medstar Health Research Institute1 site in 1 country500 target enrollmentOctober 2012

ConditionsCoronary Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Stenosis
Sponsor: Medstar Health Research Institute
Enrollment: 500
Locations: 1
Primary Endpoint: Stent length
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

January 2015

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medstar Health Research Institute

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.