PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study To Evaluate Real World Clinical Outcomes Data for the PROMUS™ Element™ Coronary Stent System in Unselected Patients in Routine Clinical Practice

Boston Scientific Corporation40 sites in 11 countries1,010 target enrollmentJune 2010

ConditionsCoronary Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Heart Disease
Sponsor: Boston Scientific Corporation
Enrollment: 1010
Locations: 40
Primary Endpoint: Target Vessel Failure (TVF)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

December 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•According to Instructions For Use

Exclusion Criteria

•Contraindications according to Instructions for Use

Outcomes

Primary Outcomes

Target Vessel Failure (TVF)

Time Frame: One year

Overall and PROMUS™ Element™ stent related TVF rate (cardiac death, myocardial infarction (MI) related to target vessel and target vessel re-intervention (TVR)) at 12 months post stent implantation.

Secondary Outcomes

Death or MI rates(30 days, 6 months, 12 months and then annually through 5 years)
Cardiac death rates(30 days, 6 months, 12 months and then annually through 5 years)
All death rates(30 days, 6 months, 12 months and then annually through 5 years)
TVR rates(30 days, 6 months, 12 months and then annually through 5 years)
MI Rates(30 days, 6 months, 12 months and then annually through 5 years)
Non-cardiac death rates(30 days, 6 months, 12 months and then annually through 5 years)
Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR)(30 days, 6 months, 12 months and then annually through 5 years)
All death or MI rates(30 days, 6 months, 12 months and then annually through 5 years)