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

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

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: XIENCE PRIMETM everolimus-eluting coronary stent

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyung-Woo Park, MD, PhD; Phone Number: 82-2-2072-0244; Email: kwparkmd@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Kyung-Woo Park, MD, PhD; Phone Number: 82-2-2072-0244; Email: kwparkmd@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XIENCE PRIMETM everolimus-eluting coronary stent	Device: XIENCE PRIMETM everolimus-eluting coronary stent; Active prospective registration of patients receiving the following stent : XIENCE PRIMETM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target Lesion Failure (TLF) rate at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	failure : CK-MB of >3 times the upper limit of normal	1 day
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Abbott

Publications and helpful links

General Publications

• Kang J, Han JK, Kang DY, Zheng C, Yang HM, Park KW, Kang HJ, Koo BK, Kim HS. SYNTAX Score and SYNTAX Score II Can Predict the Clinical Outcomes of Patients with Left Main and/or 3-Vessel Disease Undergoing Percutaneous Coronary Intervention in the Contemporary Cobalt-Chromium Everolimus-Eluting Stent Era. Korean Circ J. 2020 Jan;50(1):22-34. doi: 10.4070/kcj.2019.0097. Epub 2019 Sep 30.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimate): May 25, 2012

Study Record Updates

• Last Update Posted (Estimate): May 25, 2012
• Last Update Submitted That Met QC Criteria: May 21, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Drug eluting stent; Everolimus; XIENCE PRIME
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: H-1101-054-347