The Study to Evaluate the Safety and Efficacy of the Onyx Family

Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study

Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Onyx family

Detailed Description

For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Min Ku Chon, MD,PhD; Phone Number: 82-10-2562-6258; Email: chonmingu@gmail.com

Study Locations

• Korea, Republic of
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50611
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Min Ku Chon, MD,PhD; Phone Number: 82-10-2562-6258; Email: chonmingu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older

Description

Inclusion Criteria:

• Aged 75 or more.
• Eligible for interventional procedures.
• Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.
• Able to take antiplatelets for at least 1 months after the procedure.
• Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.

Exclusion Criteria:

• The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [eg, rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).
• Patients with active pathologic bleeding.
• Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).
• Noncardiac comorbid conditions are present with life expectancy <1 year or that may result in protocol noncompliance (per site investigator's medical judgment).
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aged 75 or more; Elderly patients aged 75 years or older	Device: Onyx family; Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents; Other Names: Resolute Onyx; Onyx frontier
Eligible for interventional procedures; "Patients requiring PCI (Percutaneous Coronary Intervention) procedure	Device: Onyx family; Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents; Other Names: Resolute Onyx; Onyx frontier
Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%; Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography	Device: Onyx family; Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents; Other Names: Resolute Onyx; Onyx frontier
Able to take antiplatelets for at least 1 months after the procedure; Patients able to take antiplatelets after the procedure	Device: Onyx family; Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents; Other Names: Resolute Onyx; Onyx frontier
Patients who underwent coronary artery procedures with ZES stent; Patients who underwent coronary artery procedures with Onyx™ family stent	Device: Onyx family; Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents; Other Names: Resolute Onyx; Onyx frontier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE at 12 months after coronary artery intervention	MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure	immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality up to 1 year after the procedure	immediately after the procedure
Cardiac mortality	Cardiac mortality up to 1 year after the procedure	immediately after the procedure
Myocardial infarction (MI)	Myocardial infarction (MI) up to 1 year after the procedure	immediately after the procedure
Cerebrovascular events	Cerebrovascular events up to 1 year after the procedure	immediately after the procedure
Target vessel revascularization (TVR)	Target vessel revascularization (TVR) up to 1 year after the procedure	immediately after the procedure
Target lesion revascularization (TLR)	Target lesion revascularization (TLR) up to 1 year after the procedure	immediately after the procedure
Stent thrombosis (ARC criteria)	Stent thrombosis (ARC criteria) up to 1 year after the procedure	immediately after the procedure
Bleeding Academic Research Consortium (BARC) type 2 to 5	Bleeding Academic Research Consortium (BARC) type 2 to 5 up to 1 year after the procedure	immediately after the procedure

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Principal Investigator: Min Ku Chon, MD,PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BRONYX STUDY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No