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

Coronary Artery Disease Clinical Trial

— HOST-ALPINE  

Official title:

Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions- Registry-based Study on the Effect and Safety of Xience Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Alpine Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845804
• Other study ID #: HOST-ALPINE
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2016
• Last updated: July 26, 2016
• Start date: July 2015
• Est. completion date: July 2021

Study information

• Verified date: July 2016
• Source: Seoul National University Hospital
• Contact: Hyo-soo Kim, MD, PhD
• Phone: +82-2-2072-2226
• Email: hyosoo[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1533
• Est. completion date: July 2021
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 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

Exclusion Criteria:

• There are no exclusion criteria for this registry.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

Device:
• Alpine

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Sejong General Hospital	Bucheon	Gyeonggi-do
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	Kangwon National University Hospital	Chuncheon	Gangwon-do
Korea, Republic of	Yongnam University Medical Center	Daegu
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Inha University Hospital	Inchon
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Gangbuk Samsung Hospital	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Seoul Boramae Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do

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