Coronary Artery DiseaseSFRGENISTANCT06104007
Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study
An observational study of Coronary Artery Disease and In-stent Restenosis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The SFRGENISTA 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 coronary in-stent restenosis (ISR). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, In-stent Restenosis
- What is being tested?
- Genoss® DCB
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2023to 31 Dec 2028
- 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: Patients with coronary in-stent restenosis who underwent percutaneous coronary intervention using the Genoss® DCB.
Who may be able to join
- Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
- Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.
Who cannot join
- Women of childbearing age who plan to become pregnant during the study duration.
- Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
- Patients for whom the expected remaining life span is less than one year.
- Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
- Patients currently involved in a randomized medical device study.
- Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.
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
Bon-Kwon Koo
Seoul
Bon-Kwon Koo, MD, PhD, +82-2-2072-2062, bkkoo@snu.ac.kr
About this study
The SFRGENISTA 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 coronary in-stent restenosis (ISR).
Read the detailed description
Drug-coated balloon (DCB) treatment is a therapeutic strategy to overcome in-stent restenosis (ISR) that occurs after drug-eluting stent (DES) implantation. The 2018 European guidelines on myocardial revascularization recommend DCB treatment in patients with bare-metal stent (BMS) or DES ISR lesions. The Sequent Please World Wide Registry has shown that DCB therapy is safe and exhibits a low target lesion revascularization (TLR) rate in a large population.
The Genoss® DCB is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. Additionally, it incorporates vitamin E, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. The catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. In a clinical trial comparing Genoss® DCB to the Sequent® Please (B-BRAUN) DCB, the in-segment late lumen loss at six months after DCB was comparable, and the rates of adverse clinical events were similar.
Given this background, this study intends to investigate the long-term efficacy and safety of the Genoss® DCB in patients with coronary ISR.
- Conditions
- Coronary Artery Disease, In-stent Restenosis
- Being tested
- Genoss® DCB
- Keywords
- Coronary Artery Disease, In-stent Restenosis, Drug-coated Balloon
- 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
This study includes patients with coronary in-stent restenosis (ISR) who have undergone percutaneous coronary intervention (PCI) according to standard treatment protocols using the Genoss® DCB and have agreed to participate in the clinical research. The decision on which drug-coated balloon (DCB) to use during PCI is entirely based on the patient's condition and the characteristics of the coronary lesions identified through angiography. Thus, it's not possible to determine in advance to use the Genoss® DCB before the procedure, nor can the number of drug-coated balloon catheters to be used during the procedure be known or decided upon beforehand.
| Study group | Role | What they receive |
|---|---|---|
| Genoss® DCB | Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB Receives: Device: Genoss® DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
A composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization
Measured: 1 year
Secondary outcomes (10)
Major adverse cardiac event
A composite of cardiac death, myocardial infarction, and revascularization
Measured: 1 year
All-cause death
All-cause death
Measured: 1 year
Cardiac death
Cardiac death
Measured: 1 year
Myocardial infarction
Myocardial infarction
Measured: 1 year
Target vessel myocardial infarction
Target vessel myocardial infarction
Measured: 1 year
Revascularization
Revascularization
Measured: 1 year
Ischemic driven target lesion revascularization
Ischemic driven target lesion revascularization
Measured: 1 year
Major bleeding (BARC type 3, 5)
Major bleeding (BARC type 3, 5)
Measured: 1 year
Stroke
Stroke
Measured: 1 ye
Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year)
Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start17 Aug 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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.
- More trials run by Seoul National University HospitalThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bon-Kwon Koo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104007
- Sponsor's protocol ID
- 2304-037-1420
- Acronym
- SFRGENISTA
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. 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 Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study
- ClinicalTrials.gov ID
- NCT06104007
- Acronym / sponsor ID
- SFRGENISTA / 2304-037-1420
- Conditions
- Coronary Artery Disease, In-stent Restenosis
- Keywords
- Coronary Artery Disease, In-stent Restenosis, Drug-coated Balloon
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 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 SFRGENISTA 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 coronary in-stent restenosis (ISR).
Detailed description
Drug-coated balloon (DCB) treatment is a therapeutic strategy to overcome in-stent restenosis (ISR) that occurs after drug-eluting stent (DES) implantation. The 2018 European guidelines on myocardial revascularization recommend DCB treatment in patients with bare-metal stent (BMS) or DES ISR lesions. The Sequent Please World Wide Registry has shown that DCB therapy is safe and exhibits a low target lesion revascularization (TLR) rate in a large population.
The Genoss® DCB is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. Additionally, it incorporates vitamin E, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. The catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. In a clinical trial comparing Genoss® DCB to the Sequent® Please (B-BRAUN) DCB, the in-segment late lumen loss at six months after DCB was comparable, and the rates of adverse clinical events were similar.
Given this background, this study intends to investigate the long-term efficacy and safety of the Genoss® DCB in patients with coronary ISR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genoss® DCB | – | Device: Genoss® DCBPatients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary in-stent restenosis who underwent percutaneous coronary intervention using the Genoss® DCB.
Key inclusion criteria (2 listed)
- Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
- Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.
Key exclusion criteria (6 listed)
- Women of childbearing age who plan to become pregnant during the study duration.
- Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
- Patients for whom the expected remaining life span is less than one year.
- Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
- Patients currently involved in a randomized medical device study.
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® DCBThis study includes patients with coronary in-stent restenosis (ISR) who have undergone percutaneous coronary intervention (PCI) according to standard treatment protocols using the Genoss® DCB and have agreed to participate in the clinical research. The decision on which drug-coated balloon (DCB) to use during PCI is entirely based on the patient's condition and the characteristics of the coronary lesions identified through angiography. Thus, it's not possible to determine in advance to use the Genoss® DCB before the procedure, nor can the number of drug-coated balloon catheters to be used during the procedure be known or decided upon beforehand. | Device | Genoss® DCB |
Primary outcome
Target lesion failure
Time frame: 1 year
A composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization
10 secondary outcomes
Major adverse cardiac event
Time frame: 1 year
All-cause death
Time frame: 1 year
Cardiac death
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Target vessel myocardial infarction
Time frame: 1 year
Revascularization
Time frame: 1 year
Ischemic driven target lesion revascularization
Time frame: 1 year
Major bleeding (BARC type 3, 5)
Time frame: 1 year
Stroke
Time frame: 1 ye
Acute stent thrombosis (within 24 hours), subacute stent thrombosis (within 30 days), late stent thrombosis (within 1 year)
Time frame: 1 year
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 27 Oct 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.
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 and In-stent Restenosis, run by Seoul National University Hospital 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 6 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 27 Oct 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 Bon-Kwon Koo, MD, PhD (+82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 1 year). 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 27 Oct 2023.