The Promus Element Rewards Study

Medstar Health Research Institute500 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

500

Conditions

Coronary Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Stent length

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.

Time frame: 1 day

Secondary Outcomes

IVUS stent length

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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