The Promus Element Rewards Study

• Conditions: Coronary Stenosis

• Registration Number: NCT01794065
• Lead Sponsor: Medstar Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-02-14
• Study First Submitted QC: 2013-02-14
• Study First Posted: 2013-02-18
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-11
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stent length	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.

Secondary Outcome Measures

Name	Time	Method
IVUS stent length	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.

Trial Locations

Locations (1)

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States