Coronary Heart Disease
Conditions
Keywords
Drug Eluting Stents, Observational, All-Comers
Brief summary
The goal of the TAXUS™ Element™ Paclitaxel-Eluting Coronary Stent System European Post-Approval Surveillance Study is to evaluate real world clinical outcomes data for the TAXUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.
Detailed description
A prospective, open label, multi-center observational study with an all-comers enrollment approach of approximately 1000 subjects at up to 50 sites in Europe.
Interventions
PROCEDURECoronary artery stenting
Coronary artery stenting with drug eluting stents
Sponsors
Pharmaceutical Research Associates
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
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 | 1 year | Overall and TAXUS Element stent related Target Vessel Failure (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 |
|---|---|---|
| MACE | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Overall and TAXUS Element stent-related Major Adverse Cardiac Events (MACE) rates (cardiac death, MI, TVR). |
| Cardiac Death or MI | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Overall and TAXUS Element stent-related cardiac death or MI rates |
| TVR | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Overall and TAXUS Element stent-related TVR rates |
| Cardiac Death | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Overall and TAXUS Element stent-related cardiac death rates |
| Stent Thrombosis | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Stent Thrombosis (ST) rate using Academic Research Consortium (ARC) definition (definite/probable with no censoring for Target Lesion Reintervention, (TLR)). |
| All Death | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | All Death rates |
| Non-Cardiac Death | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Non-Cardiac Death rates |
| All Death or MI | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | All Death or MI rates |
| MI | 30 days, 6 months, 12 months and then annually through 3 years post index stent implantation | Overall and TAXUS Element stent-related MI rates |
Countries
Belgium, France, Germany, Hungary, Ireland, Italy, Latvia, Poland, Spain, United Kingdom
Outcome results
None listed