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NCT Number: NCT06577896

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

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

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Key information

Age range

75 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50611, South Korea

Location status: Recruiting

Location contact

Min Ku Chon, MD,PhD

CONTACT

[email protected]

82-10-2562-6258

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Onyx family

Device

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: Onyx frontier, Resolute Onyx

Primary outcomes

  1. MACCE at 12 months after coronary artery intervention

    Time frame: 1 year after the procedure

    MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure

Secondary outcomes

  1. safety of procedures

    Time frame: 1 year after the procedure

    All-cause mortality

  2. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of Cardiac mortality

  3. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of myocardial infarction

  4. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of Cerebrovascular events

  5. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of Target vessel revascularization (TVR) event

  6. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of Target lesion revascularization (TLR)

  7. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of Stent thrombosis

  8. safety of procedures

    Time frame: 1 year after the procedure

    occurrence of Bleeding Academic Research Consortium (BARC) type 2 to 5 the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Min Ku Chon, MD,PhD

CONTACT

[email protected]

82-10-2562-6258

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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