Clinical trial NCT02845804: Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Angina Pectoris
Keywords: coronary artery disease
percutaneous coronary intervention
everolimus-eluting stents
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2016-07-27
Enrollment: 1533
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All coronary arterial disease patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™ stent(s)

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

Eligibility 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

Exclusion Criteria:

* There are no exclusion criteria for this registry.

Primary outcomes:
measure: Target lesion failure
timeFrame: 12 months
Secondary outcomes:
measure: Target vessel failure
timeFrame: 12 months
measure: Composite rate of cardiac death and myocardial infarction
timeFrame: 12 months, 3 years
measure: Composite rate of all-cause death and any myocardial infarction
timeFrame: 12 months, 3 years
measure: Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
timeFrame: 12 months, 3 years
measure: Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
timeFrame: 12 months, 3 years
measure: Clinical device and procedural success rate
timeFrame: intraoperative
measure: Stent thrombosis
timeFrame: within 24 hours, 1 - 30 days, 31 days - 1 year, after 1 year
Other outcomes:
Locations:
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
state: Gangwon-do
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Bucheon
country: Korea, Republic of
facility: Sejong General Hospital
state: Gyeonggi-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Cheonan
country: Korea, Republic of
facility: SoonChunHyang University Cheonan Hospital
city: Chongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yongnam University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Inchon
country: Korea, Republic of
facility: Inha University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Gangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Boramae Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-soo Kim, MD, PhD
role: STUDY_CHAIR
References: