The Promus Element Rewards Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01794065

Enrollment

500

Registered

2013-02-18

Start date

2012-10-31

Completion date

Unknown

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Stenosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results