Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis

• Conditions: Percutaneous Coronary Intervention; Acute Coronary Syndrome; Angina Pectoris; Coronary Artery Disease

• Registration Number: NCT02845804
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The objectives of this study are

1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent

2. To evaulate the long-term efficacy and safety of coronary stenting with the Xience Xpedition™/Alpine™ stent

3. To compare the long-term efficacy and safety of coronary stenting between the Xience Xpedition™/Alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

Detailed Description

Secondary endpoints of this study are

Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI

Target vessl failure

Composite rate of cardiac death and any MI, 3 years

Composite rate of all death and any MI

Composite rate of all death, any MI, and any repeat revascularization

Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Study Timeline

• Study Start: 2015-07
• Status Verified: 2016-07
• Study First Submitted: 2016-07-24
• Study First Submitted QC: 2016-07-26
• Last Update Submitted: 2016-07-26
• Study First Posted: 2016-07-27
• Last Update Posted: 2016-07-27
• Primary Completion: 2018-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1533

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

Exclusion Criteria

• There are no exclusion criteria for this registry.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure	12 months	Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Composite rate of cardiac death and myocardial infarction	12 months, 3 years
Target vessel failure	12 months	Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization	12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy	12 months, 3 years
Clinical device and procedural success rate	intraoperative
Stent thrombosis	within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year	acute (within 24 hours), subacute (1 - 30 days), late (31 days - 1 year), very late (\>1 year)
Composite rate of all-cause death and any myocardial infarction	12 months, 3 years

Trial Locations

Locations (20)

Kangwon National University Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of

Sejong General Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Korea, Republic of

Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Korea, Republic of

SoonChunHyang University Cheonan Hospital; 🇰🇷 Cheonan, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Chongju, Korea, Republic of

Yongnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

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