Clinical trial NCT05444452: GENOSS Coronary Stent Clinical Trial
Official title: Comparison Between Abluminal Biodegradable Polymer Ultrathin Sirolimus-eluting Stent and Durable-polymer Everolimus-eluting Stent (GENOSS Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: coronary stent
ischemic heart disease
acute coronary syndrome
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Genoss Company Limited, Suwon, Korea
First posted: 2022-07-06
Enrollment: 850
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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 sign informed consent voluntarily.

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

Exclusion Criteria:

* Pregnant women ② Patients unable to provide consent, ③ Patients with known intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, heparin or components of drug-eluting stents (sirolimus or everolimus)

  * Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

Primary outcomes:
measure: TLF at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: TLF at 3 years
timeFrame: 3 years
measure: Target vessel failure
timeFrame: 1 and 3 years
measure: All-cause death
timeFrame: 1 and 3 years
measure: Cardiac death
timeFrame: 1 and 3 years
measure: MI
timeFrame: 1 and 3 years
measure: Stent thrombosis
timeFrame: 1 and 3 years
measure: All-cause death or MI
timeFrame: 1 and 3 years
measure: Cardiac death or MI
timeFrame: 1 and 3 years
measure: Cardiac death, MI or stent thrombosis
timeFrame: 1 and 3 years
measure: Stroke
timeFrame: 1 and 3 years
measure: Clinically indicated TLR
timeFrame: 1 and 3 years
measure: Clinically indicated TVR
timeFrame: 1 and 3 years
measure: Any revascularization
timeFrame: 1 and 3 years
measure: Major bleeding
timeFrame: 1 and 3 years
measure: Bleeding
timeFrame: 1 and 3 years
measure: Restricted mean survival time for the TLF
timeFrame: 1 and 3 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Cardiac and Vascular Center; Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Hyeon-Cheol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: