Drug-eluting StentNCT05448625
Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)
An observational study of Drug-eluting Stent and Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features. 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
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2022to 23 Sep 2025
- 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 has signed informed consent for data release
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial (GENTLE Registry)
This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.
Read the detailed description
It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.
- Conditions
- Drug-eluting Stent, Coronary Artery Disease
- Being tested
- Genoss DES
- 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 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 |
|---|---|---|
| High Ischemic Group | 1. Acute myocardial infarction (AMI)
2. ≥ 2 stents implanted
3. bifurcation lesion
4. Left main lesion
5. Lesion treated with rotational atherectomy
6. Chronic total occlusion (CTO) lesion Receives: Device: Genoss DES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with device-oriented compopsite endpoint (TLF)
A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)
Measured: 12 months
Secondary outcomes (11)
Number of participants with patient-oriented composite endpoint
A composite rate of all death, all myocardial infarction, and all revascularization
Measured: 12 months
Number of participants with all death
A composite rate of all death
Measured: 12 months
Number of participants with cardiac death
A composite rate of cardiac death
Measured: 12 months
Number of participants with non-cardiac death
A composite rate of non-cardiac death
Measured: 12 months
Number of participants with all myocardial infarction
A composite rate of all myocardial infarction
Measured: 12 months
Number of participants with target-vessel myocardial infarction (TV-MI)
A composite rate of target-vessel myocardial infarction (TV-MI)
Measured: 12 months
Number of participants with all revascularization
A composite rate of all revascularization
Measured: 12 months
Number of participants with ischemic driven target lesion revascularization (ID-TLR)
A composite rate of ischemic driven target lesion revascularization (ID-TLR)
Measured: 12 months
Number of participants with stent thrombosis
A composite rate of stent thrombosis
Measured: Within 24 hours, 30 days, 12 months
Number of participants with non-ischemic targeted lesion perfusion
A composite rate of non-ischemic targeted lesion perfusion
Measured: 12 months
Number of participants with Non target vessel myocardial infarction
A composite rate of Non target vessel myocardial infarction
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 posted7 Jul 2022
- Study start26 May 2022
- Primary completion14 May 2025
- Study completion23 Sep 2025
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 Yonsei UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Genoss Co., Ltd.
- Responsible party
- Principal investigator, Yongcheol Kim, Yonsei University
- Investigators
- Deok-Kyu Cho, MD, PhD, Principal investigator, Yongin Severance Hopistal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448625
- Sponsor's protocol ID
- 9-2022-0014
- Status last verified
- Nov 2025
- First submitted
- 21 Jun 2022
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data set is available from the the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial (GENTLE Registry)
- ClinicalTrials.gov ID
- NCT05448625
- Acronym / sponsor ID
- 9-2022-0014
- Conditions
- Drug-eluting Stent, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Severance Hospital, Genoss Co., Ltd.
- Study start
- 26 May 2022 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 7 Jul 2022 (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.
This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.
Detailed description
It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High Ischemic Group | – | Device: Genoss DES1. Acute myocardial infarction (AMI) 2. ≥ 2 stents implanted 3. bifurcation lesion 4. Left main lesion 5. Lesion treated with rotational atherectomy 6. Chronic total occlusion (CTO) lesion |
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 (2 listed)
- Subject is ≥ 19 years
- Subject has signed informed consent for data release
Key exclusion criteria (5 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 | High Ischemic Group |
Primary outcome
Number of participants with device-oriented compopsite endpoint (TLF)
Time frame: 12 months
A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)
11 secondary outcomes
Number of participants with patient-oriented composite endpoint
Time frame: 12 months
Number of participants with all death
Time frame: 12 months
Number of participants with cardiac death
Time frame: 12 months
Number of participants with non-cardiac death
Time frame: 12 months
Number of participants with all myocardial infarction
Time frame: 12 months
Number of participants with target-vessel myocardial infarction (TV-MI)
Time frame: 12 months
Number of participants with all revascularization
Time frame: 12 months
Number of participants with ischemic driven target lesion revascularization (ID-TLR)
Time frame: 12 months
Number of participants with stent thrombosis
Time frame: Within 24 hours, 30 days, 12 months
Number of participants with non-ischemic targeted lesion perfusion
Time frame: 12 months
Number of participants with Non target vessel myocardial infarction
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 25 Nov 2025.
- Individual participant dataSharing planned: No. The data set is available from the the corresponding author upon reasonable request.
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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.
Deok-Kyu Cho, MD, PhD principal investigator
Yongin Severance Hopistal
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 Yonsei University 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 2 inclusion and 5 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 25 Nov 2025. 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?
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?
Number of participants with device-oriented compopsite endpoint (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 25 Nov 2025.