NCT05444452

GENOSS Coronary Stent Clinical Trial

Comparison Between Abluminal Biodegradable Polymer Ultrathin Sirolimus-eluting Stent and Durable-polymer Everolimus-eluting Stent (GENOSS Randomized Clinical Trial)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DEVICE	Implanatation of Genoss DES sirolimus-eluting coronary system	Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Genoss stent will be implanted if the lesion is deemed necessary to be revascularized by stenting
DEVICE	Implanatation of Xience DES everolimus-eluting coronary system	Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Xience stent will be implanted if the lesion is deemed necessary to be revascularized by stenting

Timeline

• Start date: 2022-04-24
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2022-07-06
• Last updated: 2022-07-06

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study