Coronary Artery DiseaseNCT05096442
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
A study testing GENOSS® DCB and SeQuent® Please NEO in people with Coronary Artery Disease, run by Genoss Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a novel Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-lesion late lumen loss at 6 months after the procedure in Korean patients with coronary de novo lesions compared with a product of the same category (SeQuent®… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- GENOSS® DCB and SeQuent® Please NEO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2021to 21 Nov 2023
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥19 years old
- Patients requiring PCI with coronary de novo lesions
- Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
- Women of childbearing age who agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
- In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form
- Patients with significant coronary artery stenosis (> 50% diameter stenosis on coronary angiography)
- On coronary angiography, the length of the lesion is less than 34 mm and the diameter of the reference vessel of the coronary artery is 2.0 - 4.0mm.
Who cannot join
- Patients with ST-segment elevation myocardial infarction (STEMI)
- Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
- Patients with platelet aggregation or disorders at risk of increased bleeding, such as gastrointestinal ulcers, which limit platelet aggregation inhibitory therapy and anticoagulant therapy
- Patients with a left ventricular ejection fraction of less than 30% on echocardiography
- Patients with renal insufficiency (eGFR<30mL/min)
- Patients with a history of cardiogenic shock
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- Pregnant or lactating women
- The patients have a life expectancy of less than 12 months
- Patients who have or currently have medical conditions such as psychiatric disorders that significantly affect this clinical trial
- Patients who, in the investigator's judgment, may not be suitable for this clinical trial or may increase the risk associated with participation in the study
- Patients who are currently participating in other clinical trials or have experience participating in other clinical trials within 90 days from the screening date
- Patients who are unsuitable for the study according to the investigator judges
- Patients with left main coronary lesion
- Patients with graft vessel lesion
- Patients who cannot apply pre-dilation or fail in pre-dilation to apply medical devices for clinical trials
- Patients with one of the following items after pre-dilation of the target lesion
- When FFR (Functional measurement) is measured as ≤ 0.8 in large vessels with a reference vessel diameter exceeding 2.75mm (However, depending on the judgment of the investigator, FFR measurement may not be performed.)
- Patients who need stenting due to vascular dissection that restricts blood flow
- Residual stenosis > 30%
- TIMI flow < 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Prospective, Randomized, Single-blind, Pivotal Clinical Study to Evaluate the Safety and Efficacy of GENOSS® DCB Versus SeQuent® Please NEO in Patients With Coronary De Novo Lesions
The purpose of this study is to evaluate the safety and efficacy of a novel Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-lesion late lumen loss at 6 months after the procedure in Korean patients with coronary de novo lesions compared with a product of the same category (SeQuent® Please NEO).
Read the detailed description
In a randomized controlled trial to compare with the same-category drug device (SeQuent® Please NEO), 204 patients with coronary de novo lesions were recruited from a total of 12 institutions, and the enrolled subjects were 1: 1 through randomization.
The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.
The primary end point is the in-lesion late lumen loss of the target lesion at 6 months after the procedure, and the secondary end point is the target vessel failure (Composite of cardiac death, TV-MI, and ID-TVR) at 6 and 12 months after the procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- GENOSS® DCB, SeQuent® Please NEO
- Keywords
- de novo lesions
- 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® DCBDevice
Also called Paclitaxel Coated PTCA Balloon catheter
Drug Coated Balloon
SeQuent® Please NEODevice
Also called Paclitaxel Coated PTCA Balloon catheter
Drug Coated Balloon
| Study group | Role | What they receive |
|---|---|---|
| Genoss® DCB | Experimental | Paclitaxel Coated PTCA Balloon Catheter Receives: Device: GENOSS® DCB |
| SeQuent® Please NEO | Active comparator | Paclitaxel Coated PTCA Balloon Catheter Receives: Device: SeQuent® Please NEO |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions
late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions
Measured: Follow-up angiography at 6 months after the procedure
Secondary outcomes (2)
Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions
Restenosis is defined as a case where the DS(Diameter stenosis) of the reference vessel diameter is 50% or more when the successfully treated lesion is evaluated through coronary angiography.
Measured: Follow-up angiography at 6 months after procedure
Target vessel failure(TVF)
Composite of TVF(cardiac death, TV-MI, and ID-TVR)
Measured: at 6 and 12 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start30 Sep 2021
- Primary completion28 Jun 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eun-Seok Shin, MD, PhD, Principal investigator, Division of Cardiology, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096442
- Sponsor's protocol ID
- CEP-DS1001_DN
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2021
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shin ES, Park Y, Lee JY, Her AY, Chon MK, Kim S, Rha SW, Oh GC, Cho DK, Kim B, Bae JW. A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease. JACC Asia. 2025 Jan 7;5(1):15-24. doi: 10.1016/j.jacasi.2024.10.028. eCollection 2025 Jan.
PubMed 39886190
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Single-blind, Pivotal Clinical Study to Evaluate the Safety and Efficacy of GENOSS® DCB Versus SeQuent® Please NEO in Patients With Coronary De Novo Lesions
- ClinicalTrials.gov ID
- NCT05096442
- Acronym / sponsor ID
- CEP-DS1001_DN
- Conditions
- Coronary Artery Disease
- Keywords
- de novo lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 27 Oct 2021 (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 study is to evaluate the safety and efficacy of a novel Paclitaxel-coated balloon (Genoss® DCB) by demonstrating non-inferiority to in-lesion late lumen loss at 6 months after the procedure in Korean patients with coronary de novo lesions compared with a product of the same category (SeQuent® Please NEO).
Detailed description
In a randomized controlled trial to compare with the same-category drug device (SeQuent® Please NEO), 204 patients with coronary de novo lesions were recruited from a total of 12 institutions, and the enrolled subjects were 1: 1 through randomization.
The ratio was assigned to the test group and the control group, and each of the test or control devices was assigned to receive the procedure.
The primary end point is the in-lesion late lumen loss of the target lesion at 6 months after the procedure, and the secondary end point is the target vessel failure (Composite of cardiac death, TV-MI, and ID-TVR) at 6 and 12 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genoss® DCB | Experimental | Device: GENOSS® DCBPaclitaxel Coated PTCA Balloon Catheter |
| SeQuent® Please NEO | Active comparator | Device: SeQuent® Please NEOPaclitaxel Coated PTCA Balloon Catheter |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥19 years old
- Patients requiring PCI with coronary de novo lesions
- Patients with stable angina pectoris, or unstable angina pectoris, and asymptomatic myocardial ischemia
- Women of childbearing age who agreed to use one or more of the clinically appropriate methods of contraception during the trial period.
- In case of voluntarily deciding to participate in this clinical trial by signing the informed consent form
Key exclusion criteria (20 listed)
- Patients with ST-segment elevation myocardial infarction (STEMI)
- Patients who are contraindicated in aspirin, heparin, ticagrelor, iopromide, clopidogrel, prasugrel and paclitaxel
- Patients with platelet aggregation or disorders at risk of increased bleeding, such as gastrointestinal ulcers, which limit platelet aggregation inhibitory therapy and anticoagulant therapy
- Patients with a left ventricular ejection fraction of less than 30% on echocardiography
- Patients with renal insufficiency (eGFR<30mL/min)
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® DCBAlso: Paclitaxel Coated PTCA Balloon catheterDrug Coated Balloon | Device | Genoss® DCB |
| SeQuent® Please NEOAlso: Paclitaxel Coated PTCA Balloon catheterDrug Coated Balloon | Device | SeQuent® Please NEO |
Primary outcome
in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions
Time frame: Follow-up angiography at 6 months after the procedure
late lumen loss between test group and control group evaluated by quantitative coronary analysis in patients with coronary de novo lesions
2 secondary outcomes
Restenosis rate after percutaneous coronary intervention in patients with coronary de novo lesions
Time frame: Follow-up angiography at 6 months after procedure
Target vessel failure(TVF)
Time frame: at 6 and 12 months after the procedure
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 17 May 2024.
- Derived from this study: PubMed 39886190Shin ES, Park Y, Lee JY, Her AY, Chon MK, Kim S, Rha SW, Oh GC, Cho DK, Kim B, Bae JW. A Prospective Randomized Trial Comparing 2 Different Paclitaxel-Coated Balloons in De Novo Coronary Artery Disease. JACC Asia. 2025 Jan 7;5(1):15-24. doi: 10.1016/j.jacasi.2024.10.028. eCollection 2025 Jan.
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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.
Eun-Seok Shin, MD, PhD principal investigator
Division of Cardiology, Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENOSS® DCB and SeQuent® Please NEO in people with 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 7 inclusion and 20 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 17 May 2024. 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?
in-lesion late lumen loss after percutaneous coronary intervention in patients with coronary de novo lesions (time frame: Follow-up angiography at 6 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096442, which also lists 1 linked publication.
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 17 May 2024.