CAlcified Plaque In patients receiving Resolute Onyx®

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0006069

Lead Sponsor: Jeonbuk National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

The patient must be =18 years of age.

The patient has CAD and needs to be treated with stenting. CAD includes stable angina pectoris and acute coronary syndrome (unstable angina pectoris, non-ST-elevation myocardial infarction (MI), or ST-elevation MI). Patients with chronic total occlusion are also deemed eligible.

The patient has consented to participate and has authorized the collection and release of his medical information by signing the Patient Informed Consent Form”

The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria

Patients with left main disease

Patients with cardiogenic shock

Patients who have contraindication for 12-month dual anti-platelet therapy (DAPT).

Female of childbearing potential, who possibly plans to become pregnant any time after enrollment into this study.

Patients with hypersensitivity or allergies to the drug or components indicated in the Instructions for Use of the stent.

History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.

Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

Current known platelet count <50,000 cells/mm3 or Hgb <8 g/dL.

Patients with cardiogenic shock

Patients with a life expectancy shorter than 12 months

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE(Major adverse cardiac events) is defined as the composite of cardiac death, new MI, ischemia-driven target vessel revascularization (TVR) by either PCI or CABG.

Secondary Outcome Measures

Name	Time	Method
Major adverse cardiac events;Composite of all cause death, new myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization;Acute procedure success rate during the index PCI;MACE according to calcium index of IVUS