Drug-eluting StentNCT06066450
Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis
An observational study of Drug-eluting Stent and Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Drug-eluting Stent, Coronary Artery Disease
- What is being tested?
- Genoss® DES system, Genoss® Osfit system
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2023to 31 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A patient with stenosis within 5mm of the coronary artery ostium who qualifies for percutaneous coronary intervention with drug-eluting stents
Who may be able to join
- Age 19 and above.
- Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.
- Patients who have undergone percutaneous coronary intervention for stenosis within 5mm of the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case of simultaneous stent placement for other lesions, only GenossTM drug-eluting stents should be used.)
Who cannot join
- Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.
- Patients with a life expectancy of less than 1 year.
- Pregnant or lactating women, or those wishing to become pregnant.
- Patients with ST-elevation myocardial infarction (STEMI).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Ajou University Hospital
Suwon, 16499
Je Hwan Won, MD, 82312195863, wonkwak@ajou.ac.kr
About this study
Official title: Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)
The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants.
The primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.
Read the detailed description
Investigator plan to enroll a total of 1000 patients who underwent percutaneous coronary intervention (PCI) for coronary artery stenosis within 5mm of the coronary artery ostium using OSFIT drug-eluting stents, with the condition that only GenossTM drug-eluting stents are used if stenting is performed simultaneously in other lesions. These patients will be followed for up to 12 months.
In addition, a subgroup analysis will be conducted using Optical Coherence Tomography (OCT) to assess the accuracy of OSFIT stent placement immediately after the procedure. OCT catheter use will involve the investigation and follow-up of 50 patients each at Ajou University Hospital and Samsung Seoul Hospital. Statistical analysis will involve categorical variables presented as percentages and numbers, compared using the chi-square or Fisher exact test. Continuous variables will be described using means, standard deviations, or medians and interquartile ranges and compared using Student's t-test or the Wilcoxon rank-sum test. The normality of baseline variable distributions will be assessed using histograms, skewness, kurtosis, and the Kolmogorov-Smirnov one-sample test. Kaplan-Meier analysis of cumulative rates of primary and secondary evaluation variables will be performed using the log-rank test.
To identify potential associations with clinical outcomes, all variables showing potential relevance to clinical outcomes will be tested through univariate Cox regression analysis. In order to reduce bias in retrospective studies, a multivariate Cox proportional hazard model will be used to test variables that have a significant impact (p-value < 0.1) in the univariate analysis.
Subgroup analysis will include an imaging analysis of stent insertion adequacy in the group where OCT was performed.
- Conditions
- Drug-eluting Stent, Coronary Artery Disease
- Being tested
- Genoss® DES system, Genoss® Osfit system
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genoss® DES system, Genoss® Osfit systemDevice
Also called GENOSS DES(Sirolimus Drug Eluting Coronary Stent) System, Osfit Sirolimus Drug Eluting Coronary Stent System
This is a drug-eluting stent used to improve the diameter of the coronary artery in patients with symptomatic ischemic heart disease, with de novo lesions in the native coronary artery, where the reference vessel diameter ranges from 2.25mm to 5.00mm.
| Study group | Role | What they receive |
|---|---|---|
| OSFITTM drug-eluting stents. | Treatment Group: Group of patients who received treatment with OSFITTM drug-eluting stents.
Subgroup with OCT (OCT Subgroup): Subgroup of patients who underwent Optical Coherence Tomography (OCT) to verify stent placement accuracy. Receives: Device: Genoss® DES system, Genoss® Osfit system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted lesion failure
A composite of cardiac death, target-vessel MI, or target lesion revascularization
Measured: 12 months
Secondary outcomes (7)
Major adverse cardiovascular events
A composite of all-cause death, MI, or revascularization
Measured: 12 months
All-cause death
All-cause death and cardiac death
Measured: 12 months
Any MI
Any MI and target vessel MI
Measured: 12 months
Any revascularization
Any revascularization and ischemic driven target lesion revascularization
Measured: 12 months
Major bleeding events, BARC 3, 5
A composite rate of major bleeding events, BARC 3, 5
Measured: 12 months
Any Stroke
Ischemic or hemorrhagic stroke
Measured: 12 months
Any stent thrombosis
efinite or probable stent thrombosis (acute, subacute, late)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start7 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-eluting StentStudies of the same condition, open and under way.
- More trials run by Genoss Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- seong-jae TaK, MD, PhD, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066450
- Sponsor's protocol ID
- AJOUIRBOB2023268
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of OSFIT Drug-Eluting Stent in Coronary Ostial Artery Stenosis: Multi-center, Prospective, Observational Study (OSFIT Registry)
- ClinicalTrials.gov ID
- NCT06066450
- Acronym / sponsor ID
- AJOUIRBOB2023268
- Conditions
- Drug-eluting Stent, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to evaluate the long-term effectiveness and safety of the OSFIT drug-eluting stent designed to facilitate procedures in coronary artery lesions. Additionally, the study aims to verify the accuracy of stent placement in the lesion of interest using Optical Coherence Tomography (OCT) among subgroups of participants.
The primary endpoint was defined as the composite of target lesion failure (TLF) at the 12-month mark, including cardiac death, target vessel myocardial infarction (MI), or target lesion revascularization.
Detailed description
Investigator plan to enroll a total of 1000 patients who underwent percutaneous coronary intervention (PCI) for coronary artery stenosis within 5mm of the coronary artery ostium using OSFIT drug-eluting stents, with the condition that only GenossTM drug-eluting stents are used if stenting is performed simultaneously in other lesions. These patients will be followed for up to 12 months.
In addition, a subgroup analysis will be conducted using Optical Coherence Tomography (OCT) to assess the accuracy of OSFIT stent placement immediately after the procedure. OCT catheter use will involve the investigation and follow-up of 50 patients each at Ajou University Hospital and Samsung Seoul Hospital. Statistical analysis will involve categorical variables presented as percentages and numbers, compared using the chi-square or Fisher exact test. Continuous variables will be described using means, standard deviations, or medians and interquartile ranges and compared using Student's t-test or the Wilcoxon rank-sum test. The normality of baseline variable distributions will be assessed using histograms, skewness, kurtosis, and the Kolmogorov-Smirnov one-sample test. Kaplan-Meier analysis of cumulative rates of primary and secondary evaluation variables will be performed using the log-rank test.
To identify potential associations with clinical outcomes, all variables showing potential relevance to clinical outcomes will be tested through univariate Cox regression analysis. In order to reduce bias in retrospective studies, a multivariate Cox proportional hazard model will be used to test variables that have a significant impact (p-value < 0.1) in the univariate analysis.
Subgroup analysis will include an imaging analysis of stent insertion adequacy in the group where OCT was performed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSFITTM drug-eluting stents. | – | Device: Genoss® DES system, Genoss® Osfit systemTreatment Group: Group of patients who received treatment with OSFITTM drug-eluting stents. Subgroup with OCT (OCT Subgroup): Subgroup of patients who underwent Optical Coherence Tomography (OCT) to verify stent placement accuracy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A patient with stenosis within 5mm of the coronary artery ostium who qualifies for percutaneous coronary intervention with drug-eluting stents
Key inclusion criteria (3 listed)
- Age 19 and above.
- Patients who have voluntarily decided to participate in this study and have provided written consent in accordance with the subject's agreement.
- Patients who have undergone percutaneous coronary intervention for stenosis within 5mm of the ostium of the coronary artery using OSFITTM drug-eluting stents. (In case of simultaneous stent placement for other lesions, only GenossTM drug-eluting stents should be used.)
Key exclusion criteria (4 listed)
- Patients with contraindications to stent treatment and antiplatelet therapy or who have hypersensitivity.
- Patients with a life expectancy of less than 1 year.
- Pregnant or lactating women, or those wishing to become pregnant.
- Patients with ST-elevation myocardial infarction (STEMI).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genoss® DES system, Genoss® Osfit systemAlso: GENOSS DES(Sirolimus Drug Eluting Coronary Stent) System, Osfit Sirolimus Drug Eluting Coronary Stent SystemThis is a drug-eluting stent used to improve the diameter of the coronary artery in patients with symptomatic ischemic heart disease, with de novo lesions in the native coronary artery, where the reference vessel diameter ranges from 2.25mm to 5.00mm. | Device | OSFITTM drug-eluting stents. |
Primary outcome
Targeted lesion failure
Time frame: 12 months
A composite of cardiac death, target-vessel MI, or target lesion revascularization
7 secondary outcomes
Major adverse cardiovascular events
Time frame: 12 months
All-cause death
Time frame: 12 months
Any MI
Time frame: 12 months
Any revascularization
Time frame: 12 months
Major bleeding events, BARC 3, 5
Time frame: 12 months
Any Stroke
Time frame: 12 months
Any stent thrombosis
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
seong-jae TaK, MD, PhD principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-eluting Stent and Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact seong-jae TaK, MD, PhD (820312195712, stjahk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Targeted lesion failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.