Coronary Artery DiseaseNCT03045913
Genoss DES Prospective Multicenter Registry
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Young Jin Youn, MD, PhD at 17 sites in South Korea.
Trial summary
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
- What is being tested?
- Genoss DES
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 17 sitesSouth Korea
- Study dates
- 18 Nov 2016to 31 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
Who may be able to join
- Subject is ≥ 19 years
- Subject implanted Genoss DES within 1 month
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow-up assessments
Who cannot join
- Subject did not sign informed consent for data release
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
- Pregnancy
- Subject with life expectancy less than 12 months
- Subject with cardiogenic shock
- Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
- Currently participating in another study and primary endpoint is not reached yet.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
South Korea17 sites
Kosin University Gospel Hospital
Busan
Dankook University Hospital
Cheonan, Chungcheongnam
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do
Kangwon National University Hospital
Chuncheon, Gangwon-do
Gangneung Asan Hospital
Gangneung, Gangwon-do
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do
Myongji Hospital, Hanyang University College of Medicine
Goyang-si, Gyeonggi-do
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do
Gachon University Gil Medical Center
Incheon
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
Ewha Womans University Mokdong Hospital
Seoul
Gangnam Severance Hospital
Seoul
Kangnam Sacred Heart Hospital
Seoul
Korea University Anam Hospital
Seoul
Severance Cardiovascular Hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 220060
About this study
Official title: Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Read the detailed description
Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis.
Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers.
This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.
- Being tested
- Genoss DES
- Keywords
- Observational registry, All-comers open label registry, Genoss DES, Multicenter, Stenting, Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genoss DESDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Genoss DES | Subject implanted Genoss DES for coronary artery disease Receives: Device: Genoss DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-oriented composite end point (TLF)
Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization
Measured: 12 months
Secondary outcomes (9)
Patient-oriented composite end point
Composite of any death, any myocardial infarction, and any revascularization
Measured: 12 months
Cardiac death
Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment
Measured: 12 months
Non-cardiac death
Any death not covered by the cardiac death
Measured: 12 months
Any myocardial infarction
New symptom Symptoms suggestive of ischemia + increased cardiac enzyme (Troponin >URL or CKMB >URL) or New ST elevation or LBBB
Measured: 12 months
Any myocardial infarction not clearly attributable to a nontarget vessel
Any myocardial infarction not clearly attributable to a nontarget vessel
Measured: 12 months
Any revascularization
Any repeat revascularization including all target and nontarget vessel
Measured: 12 months
Clinically indicated target-lesion revascularization
Any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Measured: 12 months
Clinically indicated target-vessel revascularization
any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
Measured: 12 months
ARC defined stent thrombosis
- Definite stent thrombosis
- Angiographic confirmation of stent thrombosis
- Pathological confirmation of stent thrombosis
- Probable stent thrombosis
- Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
- Possible stent thrombosis - Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up.
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 posted8 Feb 2017 (estimated)
- Study start18 Nov 2016
- Primary completion29 Nov 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Young Jin Youn, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Genoss Co., Ltd.
- Responsible party
- Sponsor-investigator, Young Jin Youn, MD, PhD, Yonsei University
- Investigators
- Junghan Yoon, MD, PhD, Principal investigator, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045913
- Sponsor's protocol ID
- Yonsei University
- Status last verified
- Jan 2023
- First submitted
- 23 Jan 2017
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)
- ClinicalTrials.gov ID
- NCT03045913
- Acronym / sponsor ID
- Yonsei University
- Keywords
- Observational registry, All-comers open label registry, Genoss DES, Multicenter, Stenting, Coronary Artery Disease, Coronary revascularization, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Young Jin Youn, MD, PhDUniversity, hospital or other
- Collaborators
- Genoss Co., Ltd.
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
Detailed description
Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis.
Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers.
This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genoss DES | – | Device: Genoss DESSubject implanted Genoss DES for coronary artery disease |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)
Key inclusion criteria (4 listed)
- Subject is ≥ 19 years
- Subject implanted Genoss DES within 1 month
- Subject has signed informed consent for data release
- Subject is geographically stable and willing to participate at all follow-up assessments
Key exclusion criteria (7 listed)
- Subject did not sign informed consent for data release
- Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
- Pregnancy
- Subject with life expectancy less than 12 months
- Subject with cardiogenic shock
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 DESThe 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. | Device | Genoss DES |
Primary outcome
Device-oriented composite end point (TLF)
Time frame: 12 months
Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization
9 secondary outcomes
Patient-oriented composite end point
Time frame: 12 months
Cardiac death
Time frame: 12 months
Non-cardiac death
Time frame: 12 months
Any myocardial infarction
Time frame: 12 months
Any myocardial infarction not clearly attributable to a nontarget vessel
Time frame: 12 months
Any revascularization
Time frame: 12 months
Clinically indicated target-lesion revascularization
Time frame: 12 months
Clinically indicated target-vessel revascularization
Time frame: 12 months
ARC defined stent thrombosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Junghan Yoon, MD, PhD principal investigator
Wonju Severance Christian Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Young Jin Youn, MD, PhD at 17 sites 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-oriented composite end point (TLF) (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 30 Jan 2023.