Efficacy and Safety of Xience in Coronary arEry Disease aLL-comers After stENTing Using the PRIME Platform (EXCELLENT-PRIME Registry)

Seoul National University Hospital1 site in 1 country2,000 target enrollmentMay 2011

ConditionsCoronary Artery Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Seoul National University Hospital
Enrollment: 2000
Locations: 1
Primary Endpoint: Target Lesion Failure (TLF) rate at 12 months
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Objectives:

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.
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

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

April 2015

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Hyo-Soo Kim

MD PhD

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Target Lesion Failure (TLF) rate at 12 months

Time Frame: 12 months

Secondary Outcomes

angiographic success up to 1 day(1 day)
In-stent & In-segment Late Loss at 9 months(9 months)
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)
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)
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)