Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)

Last updated: March 12, 2024
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Heart Disease

Chest Pain

Treatment

Genoss DES

Clinical Study ID

NCT05448625
9-2022-0014
  • Ages > 19
  • All Genders

Study Summary

This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is ≥ 19 years
  • Subject has signed informed consent for data release

Exclusion

Exclusion Criteria:

  • Subject did not sign informed consent for data release
  • Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any otheranticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus orcontrast media
  • Pregnancy
  • Subject with life expectancy less than 12 months
  • Subject with cardiogenic shock

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Genoss DES
Phase:
Study Start date:
May 26, 2022
Estimated Completion Date:
December 31, 2026

Study Description

It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.

Connect with a study center

  • Yongin Severance Hospital

    Yongin, Gyeonggi-do 16995
    Korea, Republic of

    Active - Recruiting

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