Coronary Artery DiseaseSTABLE-DCBNCT05438121
STabilization of Atheroma by Lipid-reducing Effect of Drug-Coated Balloon (STABLE-DCB)
An observational study of Coronary Artery Disease and Atherosclerotic Plaque, run by Korea University Ansan Hospital at 1 site in South Korea.
Trial summary
This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerotic Plaque, De Novo Stenosis
- What is being tested?
- SeQuent Please Neo
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 65 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Oct 2022to 31 Dec 2026
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with significant multi-vessel coronary artery disease requiring revascularization
Who may be able to join
- Patients with significant multivessel coronary artery disease requiring revascularization
- Any De novo lesions (reference vessel diameter of 2.25mm~4.0mm) suitable for DCB angioplasty
- Lesion suitable for intravascular imagings
- Written informed consent
Who cannot join
- Hemodynamically unstable or cardiogenic shock
- Left main stenotic lesion or graft vessel lesion
- Visible angiographic thrombus, not resolved by balloon angioplasty
- Pregnancy or breastfeeding
- Comorbidities with life expectancy < 12 months
- Severe coronary calcification or tortuosity, hindering timely DCB delivery
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
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Sunwon Kim, MD, PhD, 82-31-8099-6349, sunwon11@hanmail.net
About this study
Official title: Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
This study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
Read the detailed description
A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
- Being tested
- SeQuent Please Neo
- Keywords
- drug coated balloon, Near infrared spectroscopy, NIRS-IVUS, De novo coronary lesion
- Medical subject headings
- Coronary Artery Disease, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeQuent Please NeoDevice
DCB angioplasty will be performed in accordance with the recent recommendations. Specifically, aggressive lesion predilation (balloon-to-artery ratio: 0.8 to 1.2) using either a plain balloon or a scoring balloon will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multivessel CAD undergoing DCB PCI | I. Patients with significant multi-vessel coronary artery disease will be screened.
II. If the patient is found to have at least one lipid-rich plaque (LRP, LCBI>250) requiring revascularization (DS>70%) will undergo multi-vessel IVUS-NIRS imaging.
III. If multi-vessel NIRS screening revealed another LRP (LCBI>250) with DS<70%, the patient will be enrolled.
IV. The stenotic LRP lesion (DS>70%) will be subjected to DCB angioplasty while non-stenotic LRP lesion (DS<70%) will be left unintervened and treated medically.
V. Comparative lesions:
1. DCB-treated LRP (DS>70%, maxLCBI>250)
2. Unintervened, medically-treated LRP (DS<70%, maxLCBI>250) Receives: Device: SeQuent Please Neo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.
Measured: 6~9 month
Secondary outcomes (1)
Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.
ΔPlaque burden: IVUS-assessed changes in plaque burden between baseline and follow-up.
Measured: 6~9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start13 Oct 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Ansan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- B. Braun Korea Co., Ltd.
- Responsible party
- Principal investigator, Sunwon Kim, Korea University Ansan Hospital
- Investigators
- Sunwon Kim, MD, PhD, Principal investigator, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438121
- Sponsor's protocol ID
- AAG-O-H-2205
- Acronym
- STABLE-DCB
- Status last verified
- Oct 2024
- First submitted
- 24 Jun 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleber FX, Mathey DG, Rittger H, Scheller B; German Drug-eluting Balloon Consensus Group. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011 May;7 Suppl K:K125-8. doi: 10.4244/EIJV7SKA21. No abstract available.
PubMed 22027722Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
PubMed 31565793Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046.
PubMed 32138967
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Coated Balloon Angioplasty Facilitates Rapid Reduction in Plaque Lipid Burden in Patients with Multivessel Coronary Artery Disease: a Serial NIRS-IVUS Imaging Study
- ClinicalTrials.gov ID
- NCT05438121
- Acronym / sponsor ID
- STABLE-DCB / AAG-O-H-2205
- Keywords
- drug coated balloon, Near infrared spectroscopy, NIRS-IVUS, De novo coronary lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Korea University Ansan HospitalUniversity, hospital or other
- Collaborators
- B. Braun Korea Co., Ltd.
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jun 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 study aims to investigate whether DCB angioplasty, compared to statin-based medical treatment alone, will lead to more reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
Detailed description
A large lipid core is the hallmark of coronary plaques at risk of rupture and subsequent atherothrombosis. Although statin-based medical treatment is known to regress and stabilize lipid-rich coronary plaques, it takes time for such beneficial effects to appear. This study aims to investigate whether DCB angioplasty can effectively modify de novo coronary atherosclerotic plaque and lead to reduction in plaque lipid burden as assessed by near infrared spectroscopy (NIRS) at 6-9 months following the index procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multivessel CAD undergoing DCB PCI | – | Device: SeQuent Please NeoI. Patients with significant multi-vessel coronary artery disease will be screened. II. If the patient is found to have at least one lipid-rich plaque (LRP, LCBI>250) requiring revascularization (DS>70%) will undergo multi-vessel IVUS-NIRS imaging. III. If multi-vessel NIRS screening revealed another LRP (LCBI>250) with DS<70%, the patient will be enrolled. IV. The stenotic LRP lesion (DS>70%) will be subjected to DCB angioplasty while non-stenotic LRP lesion (DS<70%) will be left unintervened and treated medically. V. Comparative lesions: 1. DCB-treated LRP (DS>70%, maxLCBI>250) 2. Unintervened, medically-treated LRP (DS<70%, maxLCBI>250) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with significant multi-vessel coronary artery disease requiring revascularization
Key inclusion criteria (4 listed)
- Patients with significant multivessel coronary artery disease requiring revascularization
- Any De novo lesions (reference vessel diameter of 2.25mm~4.0mm) suitable for DCB angioplasty
- Lesion suitable for intravascular imagings
- Written informed consent
Key exclusion criteria (6 listed)
- Hemodynamically unstable or cardiogenic shock
- Left main stenotic lesion or graft vessel lesion
- Visible angiographic thrombus, not resolved by balloon angioplasty
- Pregnancy or breastfeeding
- Comorbidities with life expectancy < 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 |
|---|---|---|
| SeQuent Please NeoDCB angioplasty will be performed in accordance with the recent recommendations. Specifically, aggressive lesion predilation (balloon-to-artery ratio: 0.8 to 1.2) using either a plain balloon or a scoring balloon will be performed. | Device | Patients with multivessel CAD undergoing DCB PCI |
Primary outcome
Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion
Time frame: 6~9 month
ΔLCBI: NIRS-assessed changes in LCBI between baseline and follow-up.
1 secondary outcome
Difference of serially-assessed plaque burden change between DCB-treated lesion vs. medically-treated lesion.
Time frame: 6~9 month
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 15 Oct 2024.
- Background: PubMed 22027722Kleber FX, Mathey DG, Rittger H, Scheller B; German Drug-eluting Balloon Consensus Group. How to use the drug-eluting balloon: recommendations by the German consensus group. EuroIntervention. 2011 May;7 Suppl K:K125-8. doi: 10.4244/EIJV7SKA21. No abstract available.
- Background: PubMed 31565793Her AY, Shin ES, Bang LH, Nuruddin AA, Tang Q, Hsieh IC, Hsu JC, Kiam OT, Qiu C, Qian J, Ahmad WAW, Ali RM. Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group. Cardiol J. 2021;28(1):136-149. doi: 10.5603/CJ.a2019.0093. Epub 2019 Sep 30.
- Background: PubMed 32138967Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046.
- Individual participant dataSharing planned: No
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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.
Sunwon Kim, MD, PhD principal investigator
Korea University Ansan Hospital
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 Atherosclerotic Plaque, run by Korea University Ansan 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 4 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 15 Oct 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?
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 Sunwon Kim, MD, PhD (82-31-8099-6349, sunwon11@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of serially-assessed lipid core burden index (LCBI) change between DCB-treated lesion vs. medically-treated lesion (time frame: 6~9 month). 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 NCT05438121, which also lists 3 linked publications.
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 15 Oct 2024.