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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01605721
• Other study ID #: H-1101-054-347
• Status: Recruiting
• Phase: Phase 4
• First received: July 18, 2011
• Last updated: May 21, 2012
• Start date: May 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2012
• Source: Seoul National University Hospital
• Contact: Kyung-Woo Park, MD, PhD
• Phone: 82-2-2072-0244
• Email: kwparkmd[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• XIENCE PRIMETM everolimus-eluting coronary stent
Active prospective registration of patients receiving the following stent : XIENCE PRIMETM

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Abbott

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF) rate at 12 months		12 months	Yes
Secondary	In-stent & In-segment Late Loss at 9 months		9 months	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	Composite rate of cardiac death and any MI up to 3 years		up to 3 years	Yes
Secondary	Composite rate of all death and any MI up to 3 years		up to 3 years	Yes
Secondary	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	Yes
Secondary	Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy up to 3 years		up to 3 years	No
Secondary	procedural success up to 1 day	failure : CK-MB of >3 times the upper limit of normal	1 day	Yes
Secondary	angiographic success up to 1 day	success : a minimum stenosis diameter reduction to <20% in the presence of grade 3 TIMI flow (assessed by angiography)	1 day	No