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Evaluating Efficacy and Safety of Short Duration of DAPT After Genoss DES Stent Implantation in Patients

Evaluating Efficacy and Safety of Short Duration of DAPT After Genoss DES Stent Implantation in Patients

Recruiting
19 years and older
All
Phase N/A

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Overview

The investigators aimed to evaluate the safety and effectiveness of short-term DAPT (3 months for SCAD, 6 months for ACS) after PCI with Genoss DES in patients with coronary artery disease.

Description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients with coronary artery disease who have undergone percutaneous coronary intervention using the GENOSS DES stent as research subjects, collects data on the patients' clinical and surgical procedures, and reports on clinical events. The investigators will track the outbreak.

This study is a prospective, multicenter registration observational study that will enroll patients with coronary artery disease who underwent percutaneous coronary intervention with GENOSS DES at a total of five institutions.

This study is a registered observation study and does not separately calculate the number of subjects, but plans to recruit a total of 1,000 subjects during the study 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
    Acute Coronary Syndrome
    Percutaneous Coronary Intervention
    Dual Antiplatelet Therapy

NCT06075420

Genoss Co., Ltd.

27 January 2024

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