Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent

Coronary Artery Disease Clinical Trial

— GENCOMX  

Official title:

Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086496
• Other study ID #: 2022AN0320
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: Genoss Co., Ltd.
• Contact: Cheol Woong Yu
• Phone: 02-920-5445
• Email: ycw717[@]naver.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

In real-world practice, the investigators plan to evaluate the effectiveness and safety of using the GENOSS (GENOSS DES II) stent, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Description:

This study will enroll patients who underwent percutaneous coronary intervention using the GENOSS DES stent.

This study is a single-arm, registry, observational study, so it is not necessary to calculate the number of subjects, but the investigators plan to enroll approximately 1,000 patients at 7 institutions during the registration period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Adults over 19 years of age

2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.

3. Severe coronary artery stenosis suitable for Genoss stent insertion

4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution.

Exclusion Criteria:

1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)

2. Patients who also received other drug-eluting stents

3. If you have a disease with a remaining life expectancy of less than 1 year

4. Pregnant or lactating women or women who may be pregnant

5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low.

6. Patients judged by researchers to be unsuitable for research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Percutaneous Coronary Intervention

Intervention

Device:
• Genoss DES stent
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genoss Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	device-oriented composite end point	The composite rate of cardiac death, TVMI, and TL will be evaluated by the incidence of target lesion failure(TLF).	12 months
Secondary	patient-oriented composite end point	1 year all death incidence rate (All deaths); 1 year cardiac death rate; 1-year target vessel myocardial infarction incidence rate (TVMI); year all-vascular myocardial infarction incidence rate (any MI) 1-year ischemia-driven target vessel revascularization (ischemia driven TVR) 1-year ischemia-induced target lesion revascularization (ischemia driven TLR) 1-year stent thrombosis (ARC standard)	12 months