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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Device: XIENCE PRIMETM everolimus-eluting coronary stent

• Registration Number: NCT01605721
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-18
• Status Verified: 2012-05
• Study First Submitted QC: 2012-05-21
• Last Update Submitted: 2012-05-21
• Study First Posted: 2012-05-25
• Last Update Posted: 2012-05-25
• Primary Completion: 2013-04
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
XIENCE PRIMETM everolimus-eluting coronary stent	XIENCE PRIMETM everolimus-eluting coronary stent	-

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF) rate at 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
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)
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	failure : CK-MB of \>3 times the upper limit of normal

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of