Effect and Efficacy of Xpedition™/Alpine™, Everolimus-eluting Stent for Coronary Atherosclerosis
- Conditions
- Percutaneous Coronary InterventionAcute Coronary SyndromeAngina PectorisCoronary Artery Disease
- Interventions
- Device: Alpine
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1533
- 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
- There are no exclusion criteria for this registry.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alpine Alpine The patients who received percutaneous coronary intervention with Xience Xpedition™/Alpine™
- 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 12 months, 3 years 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)
Trial Locations
- Locations (20)
SoonChunHyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chongju, Korea, Republic of
Inha University Hospital
🇰🇷Inchon, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Presbyterian Medical Center
🇰🇷Jeonju, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul Boramae Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Gangwon-do, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon, Gangwon-do, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Sejong General Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
Yongnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Gangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of