Coronary Artery Disease
Conditions
Keywords
Everolimus, XIENCE PRIME, Drug eluting stent
Brief summary
Objectives: 1. To evaluate the safety and long-term effectiveness of coronary stenting with the XIENCE PRIMETM in a cohort of real world patients and lesion subsets. 2. To determine clinical device and procedural success during commercial use of XIENCE PRIMETM coronary stent Study population : Approximately consecutive 2000 patients treated with XIENCE PRIMETM Study period * Patient enrollment: 2011.05 \ 2012.04 * End of follow-up period: 2015. 02 (3 years of follow-up) Primary endpoint : Target Lesion Failure (TLF) rate at 12 months Secondary endpoint: * In-stent & In-segment Late Loss at 9 months * Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late) * Target Vessel Failure at 12 months (composite of cardiac death, MI, and TVR) * Any death, cardiac death, MI, TLR, TVR at 30 days, 9months, 1 year, 3 years * Composite rate of cardiac death and any MI up to 3 years * Composite rate of all death and any MI up to 3 years * Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years * Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years * Procedural success up to 1 day * Angiographic success up to 1 day
Interventions
DEVICEXIENCE PRIMETM everolimus-eluting coronary stent
Active prospective registration of patients receiving the following stent : XIENCE PRIMETM
Sponsors
Abbott
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form. Angiographic Inclusion Criteria * There are no angiographic inclusion criteria for this study.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target Lesion Failure (TLF) rate at 12 months | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Thrombosis at 24 hours (acute), 30 days (subacute), 1 year (late), yearly up to 3 years (very late) | 24 hours, 30 days, up to 3 years | — |
| Any death, cardiac death, MI, TLR, TVR at 30 days, 9 months, 1 year, 3 years | 30 days, 9 months, 1 year, up to 3 years | — |
| Composite rate of cardiac death and any MI up to 3 years | up to 3 years | — |
| Composite rate of all death and any MI up to 3 years | up to 3 years | — |
| In-stent & In-segment Late Loss at 9 months | 9 months | — |
| Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years | up to 3 years | — |
| procedural success up to 1 day | 1 day | failure : CK-MB of \>3 times the upper limit of normal |
| angiographic success up to 1 day | 1 day | success : a minimum stenosis diameter reduction to \<20% in the presence of grade 3 TIMI flow (assessed by angiography) |
| Composite rate of all death, any MI (Q-wave and non Q-wave) and any repeat revascularization up to 3 years | up to 3 years | — |
Countries
South Korea
Contacts
Primary ContactKyung-Woo Park, MD, PhD
Outcome results
None listed