GENOSS Coronary Stent Clinical Trial

Last updated: June 29, 2022
Sponsor: Samsung Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Thrombosis

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT05444452
GENOSS
  • Ages > 19
  • All Genders

Study Summary

This study aims to evaluate the efficacy and safety of abluminal biodegradable polymer ultrathin sirolimus-eluting stent (Genoss stent) as compared with a durable-polymer everolimus-eluting stent (Xience stent) in patients with coronary artery disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

① Subject must be at least 19 years of age

② Subject who is able to understand risks, benefits and treatment alternatives and signinformed consent voluntarily.

③ Patients with stable coronary artery disease or acute coronary syndrome and at least onelesion with greater than 50% diameter stenosis suitable for stent implantation

Exclusion

Exclusion Criteria:

  • Pregnant women ② Patients unable to provide consent, ③ Patients with known intoleranceto aspirin, clopidogrel, ticagrelor, prasugrel, heparin or components of drug-elutingstents (sirolimus or everolimus)
  • Patients who have non-cardiac co-morbid conditions with life expectancy <1 yearor that may result in protocol non-compliance (per site investigator's medicaljudgment)

Study Design

Total Participants: 850
Study Start date:
April 24, 2022
Estimated Completion Date:
June 30, 2027

Study Description

After the introduction of the drug-eluting stents (DES), the rates of device-related failure or target lesion failure (TLF) such as restenosis has been markedly decreased, compared with the era of bare-metal stents. Nevertheless, the risk of ischemic events including very late stent thrombosis after percutaneous coronary intervention (PCI) has still remained even though the use of DES, presumably because of hypersensitivity to the polymer with persistent inflammation and delayed re-endothelialization. To overcome these issues, second-generation DES with thinner stent strut and biocompatible or biodegradable polymer were developed. Several trials demonstrated that second-generation DES provides more favorable outcome in comparison with first-generation DES. Especially, among second-generation DES, biodegradable polymer DES showed better ischemic outcomes compared to durable polymer DES in some studies.

Genoss DES™ (Genoss Company Limited, Suwon, Korea) is one of newer second-generation DESs with a cobalt-chromium platform with an abluminal biodegradable polymer containing sirolimus. The Genoss DES™ is the first Korean sirolimus-eluting stent on the market and it has ultrathin strut with 70 μm strut thickness with 3 μm thin abluminal polymer coating containing Sirolimus. The polymer is designed to release approximately 70% of the total drug amount within 30 days of the implantation and is entirely absorbable within 9 months. Thus, only the metal component of the stent will remain. In the first-in-man trial comparing Genoss DES™ and Promus Element™ stent (Boston Scientific Co., Natick, MA, USA), angiographic and clinical outcomes were similar at a 9-month follow-up. However, the study was too small to conclude that the Genoss DES™ is safe and efficient for de novo coronary stenosis. To date, there has been no large-scale randomized trial evaluating the safety and efficacy of Genoss DES™.

Therefore, the purpose of this trial is to determine the efficacy and safety of Genoss DES™ as compared with Xience everolimus-eluting stent (Abbott Vascular, Santa Clara, California, USA) which is widely used and has proven efficacy and safety.

Connect with a study center

  • Cardiac and Vascular Center; Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Active - Recruiting

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