Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES) (GENCOMX)

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)

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, 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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention
• Intervention / Treatment: Device: GENOSS® DES Sirolimus Eluting Coronary Stent System

Detailed Description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent.

As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions during the study registration period.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• South Korea
  • Seoul
    • Seoul, Seoul, South Korea
      • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Coronary artery disease patients who underwent coronary intervention using the GENOSS® DES

Description

<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® DES 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]; Patients with coronary artery disease who require interventional treatment through stent insertion in real-world practice (all-comer)	Device: GENOSS® DES Sirolimus Eluting Coronary Stent System; The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)	at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death		at 12 months after the procedure
Stent thrombosis by ARC definition		at 12 months after the procedure
TV-MI (target vessel-myocardial infarction)		at 12 months after the procedure
ID-TVR (ischemia-driven target vessel revascularization)		at 12 months after the procedure
All deaths		at 12 months after the procedure
any MI (myocardial infarction)		at 12 months after the procedure
ID-TLR (ischemia-driven target lesion revascularization)		at 12 months after the procedure
Procedure success	When the final internal stenosis rate is less than 30% as assessed visually on angiography after the procedure and there is no death, Q-wave myocardial infarction, or urgent revascularization during hospitalization.	during the hospitalization period (up to 3 days)

Collaborators and Investigators

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2022AN0320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data set is available from the the corresponding author upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No