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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: XIENCE PRIMETM everolimus-eluting coronary stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01605721

H-1101-054-347

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 exclusion criteria for this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

XIENCE PRIMETM everolimus-eluting coronary stent

Experimental group

Treatment:

Device: XIENCE PRIMETM everolimus-eluting coronary stent