Coronary Heart Disease
Conditions
Keywords
Coronary stenting, Drug-eluting stent, Post-market surveillance study, Promus Element stent
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.
Interventions
DEVICECoronary 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.
Sponsors
Pharmaceutical Research Associates
Medidata Solutions
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* According to Instructions For Use
Exclusion criteria
* Contraindications according to Instructions for Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 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
| Measure | Time frame | Description |
|---|---|---|
| Death or MI rates | 30 days, 6 months, 12 months and then annually through 5 years | Overall and PROMUS™ Element™ stent-related cardiac death or MI rates |
| TVR rates | 30 days, 6 months, 12 months and then annually through 5 years | Overall and PROMUS™ Element™ stent-related TVR rates. |
| Cardiac death rates | 30 days, 6 months, 12 months and then annually through 5 years | Overall and PROMUS™ Element™ stent-related cardiac death rates. |
| Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR) | 30 days, 6 months, 12 months and then annually through 5 years | Overall and PROMUS™ Element™ stent-related MACE rates (cardiac death, MI, TVR). |
| All death rates | 30 days, 6 months, 12 months and then annually through 5 years | All death rates |
| Non-cardiac death rates | 30 days, 6 months, 12 months and then annually through 5 years | Non-cardiac death rates |
| All death or MI rates | 30 days, 6 months, 12 months and then annually through 5 years | All death and MI rates |
| MI Rates | 30 days, 6 months, 12 months and then annually through 5 years | Overall and PROMUS™ Element™ stent-related MI rates. |
Countries
Austria, Belgium, Denmark, France, Germany, Hungary, Ireland, Italy, Netherlands, Spain, United Kingdom
Outcome results
None listed