The Promus Element Rewards Study

Coronary Stenosis Clinical Trial

Official title:

The Promus Element Rewards Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01794065
• Other study ID #: REWARDS PE
• Status: Active, not recruiting
• Phase: N/A
• First received: February 14, 2013
• Last updated: August 8, 2014
• Start date: October 2012

Study information

• Verified date: August 2014
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Stenosis

Locations

Country	Name	City	State
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day	No
Secondary	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.	1 day	No