Coronary Artery Disease(CAD)PCB-De NovoNCT07158307
Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion
An observational study of Coronary Artery Disease(CAD), run by Genoss Co., Ltd. at 1 site in South Korea.
Trial summary
The GENOSS PCB-De Novo study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with De novo small coronary artery disease. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease(CAD)
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jun 2024to 30 Jun 2031
- How long will I take part?
- 3 Years
- 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: Subjects who underwent PCI with GENOSS DCB for small coronary artery disease with de novo lesions
Who may be able to join
- Adults over the age of 19
- Patients with new lesions with coronary small vascular disease (vascular diameter <3.0 mm) underwent a GENOSS® DCB procedure through percutaneous coronary intervention
- Subjects who agreed to the clinical research plan and the clinical follow-up plan, voluntarily decided to participate in this clinical study, and agreed in writing to the consent of the study subjects
Who cannot join
- Subjects who plan to become pregnant during the period of this study as women of the gestational age
- Subjects whose remaining life expectancy is expected to be less than one year
- Subjects who visited the hospital due to psychogenic shock at the time of visiting the hospital and are predicted to have a low chance of survival based on medical judgment
- If it falls under any of the following items after prior dilation of the target lesion;
- Stent procedures are required due to vascular detachment that limits blood flow
- If the residual stenosis is >30%
Show all 9Show fewer
- If the TIMI flow is <3
- Subjects participating in a randomized study of medical devices
- If the researcher determines that it is not appropriate for this clinical study or may increase the risk associated with participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of Paclitaxel-coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With De Novo Lesion of Small Coronary Artery Disease: A Prospective, Multi-center, Observational Study
The GENOSS PCB-De Novo study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with De novo small coronary artery disease.
Read the detailed description
This prospective, open-label, multicenter, observational study will enroll patients with de novo small coronary artery disease undergoing PCI with the GENOSS® DCB at 47 hospitals.
Because this is an observational study, the number of participants will not be calculated separately, but a total of 3,000 participants are planned to be recruited during the study enrollment period.
All patients will be followed up at 1, 2, and 3 years postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTCA balloon catheter.
- Conditions
- Coronary Artery Disease(CAD)
- 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.
| Study group | Role | What they receive |
|---|---|---|
| GENOSS® DCB (Paclitaxel-coated PTCA Balloon Catheter) | Patients with de novo small coronary artery disease who underwent PCI with GENOSS DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure (TLF)
composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
Measured: at 1 year after the procedure
Secondary outcomes (6)
Target lesion failure (TLF)
composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
Measured: at 2, 3 years after the procedure
Major cardiac adverse events (MACE)
composite endpoint of death, myocardial infarction, and revascularization
Measured: at 1, 2, 3 years after the procedure
all mortality
all deaths and cardiac deaths
Measured: at 1, 2, 3 years after the procedure
any MI
all myocardial infarction and target vessel myocardial infarction (TV-MI)
Measured: at 1, 2, 3 years after the procedure
all revascularization and ischemia-driven target lesion revascularization (ID-TLR)
Measured: at 1, 2, 3 years after the procedure
major bleeding event
BARC 3, 5
Measured: at 1, 2, 3 years 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 posted5 Sep 2025
- Study start27 Jun 2024
- Primary completion27 Jun 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease(CAD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158307
- Sponsor's protocol ID
- CIP-DS1001-3
- Acronym
- PCB-De Novo
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Paclitaxel-coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With De Novo Lesion of Small Coronary Artery Disease: A Prospective, Multi-center, Observational Study
- ClinicalTrials.gov ID
- NCT07158307
- Acronym / sponsor ID
- PCB-De Novo / CIP-DS1001-3
- Conditions
- Coronary Artery Disease(CAD)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 27 Jun 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 5 Sep 2025 (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 GENOSS PCB-De Novo study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with De novo small coronary artery disease.
Detailed description
This prospective, open-label, multicenter, observational study will enroll patients with de novo small coronary artery disease undergoing PCI with the GENOSS® DCB at 47 hospitals.
Because this is an observational study, the number of participants will not be calculated separately, but a total of 3,000 participants are planned to be recruited during the study enrollment period.
All patients will be followed up at 1, 2, and 3 years postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTCA balloon catheter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENOSS® DCB (Paclitaxel-coated PTCA Balloon Catheter) | – | –Patients with de novo small coronary artery disease who underwent PCI with GENOSS DCB |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who underwent PCI with GENOSS DCB for small coronary artery disease with de novo lesions
Key inclusion criteria (3 listed)
- Adults over the age of 19
- Patients with new lesions with coronary small vascular disease (vascular diameter <3.0 mm) underwent a GENOSS® DCB procedure through percutaneous coronary intervention
- Subjects who agreed to the clinical research plan and the clinical follow-up plan, voluntarily decided to participate in this clinical study, and agreed in writing to the consent of the study subjects
Key exclusion criteria (9 listed)
- Subjects who plan to become pregnant during the period of this study as women of the gestational age
- Subjects whose remaining life expectancy is expected to be less than one year
- Subjects who visited the hospital due to psychogenic shock at the time of visiting the hospital and are predicted to have a low chance of survival based on medical judgment
- If it falls under any of the following items after prior dilation of the target lesion;
- Subjects participating in a randomized study of medical devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target lesion failure (TLF)
Time frame: at 1 year after the procedure
composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
6 secondary outcomes
Target lesion failure (TLF)
Time frame: at 2, 3 years after the procedure
Major cardiac adverse events (MACE)
Time frame: at 1, 2, 3 years after the procedure
all mortality
Time frame: at 1, 2, 3 years after the procedure
any MI
Time frame: at 1, 2, 3 years after the procedure
all revascularization and ischemia-driven target lesion revascularization (ID-TLR)
Time frame: at 1, 2, 3 years after the procedure
major bleeding event
Time frame: at 1, 2, 3 years after the procedure
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 5 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease(CAD)
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Anaesthetic Management in Patients Undergoing Coronary Artery Bypass Grafting
Preoperative Fasting, Pulmonary Aspiration During Anesthetic Induction
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease(CAD), 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 9 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: enrolling by invitation, as of the sponsor's last update on 5 Sep 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?
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?
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?
Target lesion failure (TLF) (time frame: at 1 year after the procedure). 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 5 Sep 2025.