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Evaluating Efficacy and Safety of 1-year of DAPT After Genoss DES Sirolimus-eluting Stent Implantation in Patients

Evaluating Efficacy and Safety of 1-year of DAPT After Genoss DES Sirolimus-eluting Stent Implantation in Patients

Recruiting
19 years and older
All
Phase N/A

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Overview

In this prospective, multicenter observational study, The investigators evaluated the safety and effectiveness of DAPT over 1 year in all patients with coronary artery disease, including patients with complex high-risk coronary artery disease (CHIP), who underwent PCI using the Genoss DES stent, and performed subgroup analysis. Through this, the investigators aim to determine whether there are differences in safety and effectiveness depending on whether or not the patient is a subject with complex high-risk coronary artery disease.

Description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients with coronary artery disease who underwent PCI using the GENOSS DES drug-eluting stent as research subjects, collects data on Honaza's clinical practice and procedures, and determines the occurrence of clinical events. The investigators will track this.

This study is a prospective, multicenter study enrolling patients with coronary artery disease who underwent percutaneous coronary intervention with GENOSS DES. A total of eight institutions will recruit subjects.

This study is a registered observation study and does not calculate a separate number of subjects, but plans to recruit a total of 1,000 subjects during the study registration period.

Eligibility

Inclusion Criteria:

  1. Adults aged 19 or older
  2. Subjects treated for coronary artery disease using the Genoss DES™ stent
  3. Subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and provide written consent in the research subject consent form.

Exclusion Criteria:

  1. Psychogenic shock at the time of hospitalization
  2. Expecting to become pregnant, pregnant or lactating woman
  3. In cases where the remaining survival period is expected to be less than 1 year due to a concomitant medical disease
  4. Subjects participating in other medical device randomization studies
  5. Subjects who received treatment using a different DES or BMS at the time of registration (however, due to failure of Genoss DES™ stent insertion, insertion of other stents is allowed)

Study details
    Coronary Artery Disease
    Percutaneous Coronary Intervention
    Dual Antiplatelet Therapy

NCT06075433

Genoss Co., Ltd.

26 January 2024

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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