Status:

RECRUITING

Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure

Lead Sponsor:

Genoss Co., Ltd.

Conditions:

Coronary Artery Disease

Percutaneous Coronary Intervention

Eligibility:

All Genders

19+ years

Brief Summary

The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (a...

Detailed Description

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previou...

Eligibility Criteria

Inclusion

  • Patients of 19 and over
  • Patients with coronary artery disease treated with GENOSS SES
  • Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion

  • Patients with cardiogenic shock at the time of hospitalization
  • Patients who are pregnant or planning to become pregnant
  • Patients with a life expectancy of less than 1 year
  • Patients participating in randomized controlled trials using other medical devices
  • Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)

Key Trial Info

Start Date :

May 13 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 31 2027

Estimated Enrollment :

1000 Patients enrolled

Trial Details

Trial ID

NCT06075433

Start Date

May 13 2022

End Date

December 31 2027

Last Update

February 21 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Wonju Severance Christian Hospital

Wŏnju, Gangwon State, South Korea