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CAlcified Plaque In patients receiving Resolute Onyx®

CAlcified Plaque In patients receiving Resolute Onyx®

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006069
Enrollment
300
Registered
2021-04-07
Start date
2018-07-31
Completion date
Unknown
Last updated
2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Jeonbuk National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJawon Lee

Jeonbuk National University Hospital

jwlee@jbct.kr+82-3267

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026