Overview

This trial is active, not recruiting.

Condition coronary heart disease
Treatment coronary stenting
Sponsor Boston Scientific Corporation
Collaborator Pharmaceutical Research Associates, Inc.
Start date June 2010
End date May 2012
Trial size 1010 participants
Trial identifier NCT01148329, S2057

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
To evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice
coronary stenting
The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.

Primary Outcomes

Measure
Target Vessel Failure (TVF)
time frame: One year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - According to Instructions For Use Exclusion Criteria: - Contraindications according to Instructions for Use

Additional Information

Official title 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
Principal investigator Martyn R Thomas, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.