In-stent RestenosisGENISPIRENCT05656118
Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR)
An observational study of In-stent Restenosis, run by Yonsei University at 10 sites in South Korea.
Trial summary
The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients. The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- In-stent Restenosis
- What is being tested?
- Genoss® DCB
- Type of treatment
- Medical device
- How many people
- 260 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 31 Aug 2022to 31 Dec 2028
- How long will I take part?
- 12 Months
- 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 treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR)
Who may be able to join
- ① Age ≥18 years old.
- ② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.
- ③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
Who cannot join
- A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.
- Patients with life expectancy less than 1 year.
- Patients with cardiogenic shock and are predicted to have a low survival rate based on medical judgment.
- Patients participating in a medical device randomized controlled trials. ⑥ Patients who, in the judgment of the investigator, are not suitable for this clinical study or may increase the risks associated with participation in the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Kosin University Gospel Hospital
Busan, Busan, 49267
Kangwon National University Hospital
Chuncheon, Gangwon-do, 24289
Kyungpook National University College Hospital
Daegu, Gyeongsangnam-do, 136-705
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380
National Health Insurance Service Ilsan Hospital
Goyang-si, Gyeonggi-do, 10444
Jeonbuk National University Hospital
Jeonju, Jeollabuk-do, 54907
Korea University ANAM Hospital
Seoul, Seoul, 02841
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Yongin Severance Hospital, Yonsei University
Yongin-si, Gyeonggi-do, 16995
About this study
Official title: Safety and Efficacy of Paclitax Drug Coated Balloon Catheter (Genoss® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study (GENISPIRE Registry)
The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.
The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.
Read the detailed description
260 subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR) will be recruited and followed up to 12 months.
All enrolled patients treated with Genoss DCB in patients with coronary in-stent restenosis (ISR) will be included in the analysis unless there is a valid reason or rationale for it, and the final statistical analysis will follow the intention-to-treat (ITT) principle as assigned. Standard descriptive statistics will be used for patient baseline characteristics, lesions, procedures, and clinical event outcomes. Categorical variables will be presented as percentages and numbers and compared using chi-square or Fisher's exact test. Continuous variables will appear as mean, standard deviation or median, and interquartile range, and will be compared with Student's T-test or Wilcoxon rank sum test, and the normal value of the standard variable distribution will be predicted through histogram, skewness, kurtosis, and Kolmogorov Smirnov one sample test.
- Conditions
- In-stent Restenosis
- Being tested
- Genoss® DCB
- Keywords
- In-stent Restenosis, Drug-coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genoss® DCBDevice
Paclitaxel coated balloon with a shellac plus vitamin E excipient
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel Coated Balloon | Patients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR) Receives: Device: Genoss® DCB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Targeted lesion failure
A composite of cardiac death, target-vessel MI, or target lesion revascularization
Measured: 12 months
Secondary outcomes (7)
Major adverse cardiovascular events
A composite of all-cause death, MI, or revascularization
Measured: 12 months
All-cause death
All-cause death and cardiac death
Measured: 12 months
Any MI
Any MI and target vessel MI
Measured: 12 months
Any revascularization
Any revascularization and ischemic driven target lesion revascularization
Measured: 12 months
Major bleeding events, BARC 3, 5
A composite rate of major bleeding events, BARC 3, 5
Measured: 12 months
Any Stroke
Ischemic or hemorrhagic stroke
Measured: 12 months
Any stent thrombosis
Definite or probable stent thrombosis (acute, subacute, late)
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 posted19 Dec 2022
- Study start31 Aug 2022
- Primary completion31 Dec 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 In-stent RestenosisStudies 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
- 260 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deok-Kyu Cho, Yonsei University
- Investigators
- Deok-Kyu Cho, MD, Principal investigator, Yongin Severance Hospital, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656118
- Sponsor's protocol ID
- 9-2022-0063
- Acronym
- GENISPIRE
- Status last verified
- Jul 2025
- First submitted
- 11 Dec 2022
- Last updated
- 8 Jul 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Paclitax Drug Coated Balloon Catheter (Genoss® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study (GENISPIRE Registry)
- ClinicalTrials.gov ID
- NCT05656118
- Acronym / sponsor ID
- GENISPIRE / 9-2022-0063
- Conditions
- In-stent Restenosis
- Keywords
- In-stent Restenosis, Drug-coated balloon
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Dec 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.
The purpose of this observational study was to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter in coronary in-stent restenosis (ISR) patients.
The primary endpoint was target lesion failure (TLF, a composite of cardiac death, target-vessel MI, or target lesion revascularization) at 12 months.
Detailed description
260 subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR) will be recruited and followed up to 12 months.
All enrolled patients treated with Genoss DCB in patients with coronary in-stent restenosis (ISR) will be included in the analysis unless there is a valid reason or rationale for it, and the final statistical analysis will follow the intention-to-treat (ITT) principle as assigned. Standard descriptive statistics will be used for patient baseline characteristics, lesions, procedures, and clinical event outcomes. Categorical variables will be presented as percentages and numbers and compared using chi-square or Fisher's exact test. Continuous variables will appear as mean, standard deviation or median, and interquartile range, and will be compared with Student's T-test or Wilcoxon rank sum test, and the normal value of the standard variable distribution will be predicted through histogram, skewness, kurtosis, and Kolmogorov Smirnov one sample test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Coated Balloon | – | Device: Genoss® DCBPatients treated with Genoss® DCB in patients with coronary artery in-stent restenosis (ISR) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects treated with a paclitaxel-coated balloon (Genoss® DCB) in patients with coronary in-stent restenosis (ISR)
Key inclusion criteria (3 listed)
- ① Age ≥18 years old.
- ② Patients treated with Genoss® DCB in coronary artery In-stent restenosis (ISR) patients.
- ③ Patients who can understand the purpose of the study and voluntarily participate in and sign informed consent.
Key exclusion criteria (4 listed)
- A woman who is pregnant, lactating, or planning a pregnancy. ② Patients who are scheduled for surgery requiring discontinuation of antiplatelet drugs within 12 months.
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® DCBPaclitaxel coated balloon with a shellac plus vitamin E excipient | Device | Paclitaxel Coated Balloon |
Primary outcome
Targeted lesion failure
Time frame: 12 months
A composite of cardiac death, target-vessel MI, or target lesion revascularization
7 secondary outcomes
Major adverse cardiovascular events
Time frame: 12 months
All-cause death
Time frame: 12 months
Any MI
Time frame: 12 months
Any revascularization
Time frame: 12 months
Major bleeding events, BARC 3, 5
Time frame: 12 months
Any Stroke
Time frame: 12 months
Any stent thrombosis
Time frame: 12 months
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 8 Jul 2025.
- Individual participant dataSharing planned: No. The data set is available from the the corresponding author upon reasonable request.
Related trials for In-stent Restenosis
Not yet recruiting
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
Coronary In-stent Restenosis, Coronary Artery Disease
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
In-Stent Restenosis
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Recruiting
First-in-Human Study Using the SiroMax™ Sirolimus-Coated Balloon Catheter as a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheter to Treat Subjects Who Have Coronary Artery Disease (CAD) Involving In-Stent Restenosis (ISR) or an Unstented Lesion in a Small Coronary Vessel (DNSV).
Coronary Artery Disease, Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
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 principal investigator
Yongin Severance Hospital, Yonsei University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-stent Restenosis, run by Yonsei University at 10 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
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?
Targeted lesion failure (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 8 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.