Chinese Patients Treated With Agent DCBNCT04085445
An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients
An observational study of Chinese Patients Treated With Agent DCB, run by Boston Scientific Corporation at 9 sites in 3 countries.
Trial summary
To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chinese Patients Treated With Agent DCB
- What is being tested?
- AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 13 Nov 2019to 3 Sep 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All enrolled subjects will be eligible for evaluation. The inclusion and exclusion criteria for the Agent DCB Registry study are listed in the following sections.
Who may be able to join
- Chinese subject at least 18 years of age(or meet age requirements per local law).
- Subject (or legal guardian) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Subject who has ischemic symptoms or evidence of myocardial ischemia and is clinically indicated for PCI and will be treated with Agent DCB.
- Subject is willing to comply with all protocol-required follow-up evaluation.
- In women with childbearing potential a negative pregnancy test is mandatory.
- Subject with no known intolerance to paclitaxel and no contraindications to antiplatelet regimen.
Who cannot join
- Exclusion criteria are not required in the Agent DCB registry study as it is an "all comers" study.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Taiwan7 sites
Hualien Tzu Chi Hospital
Hualien City, 970
Kaohsiung Veterans General Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Cheng Hsin General Hospital
Taipei
Mackay Memorial Hospital
Taipei
National Taiwan University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
About this study
Official title: Agent DCB Registry
To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.
Read the detailed description
The Agent DCB Registry study will enroll 500 subjects at up to 10 investigational sites in Taiwan, Hong-Kong and Singapore.
If participants decide to participate in this study, participants will first be asked to sign and date this consent form. If participants sign the consent form, participants will go through a baseline/ procedure process. Information about participants and participants' health will be collected and participants will have a limited physical examination.
Participants will need to have the laboratory tests (including myocardial enzyme test before and post the index procedure, pregnancy test before the index procedure) and other assessments to find out if participants meet the requirements to be in the study and to ensure it is safe for participants to have the procedure. These tests and assessments are part of routine care and may be done even if participants do not join the study. If participants have had some of them recently, they may not need to be repeated.
Participants will be expected to follow the scheduled follow-ups which occur at 30 days, 6 and 12 months, and then annually through 3 years post the index procedure for all enrolled subjects. Angiographic follow-up will perform at 9 months post index procedure for all the subjects with small vessel lesions and the first 100 consecutively enrolled subjects with ISR lesions. Enrolled subjects with the failure of advancing Agent DCB across target lesion will be followed through hospital discharge following the initial attempted index procedure.
Participants' participation in the study will be completed after approximately 3 years.
- Conditions
- Chinese Patients Treated With Agent DCB
- Being tested
- AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter
- Keywords
- Agent DCB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon CatheterDevice
To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with 12 months post index procedure
Major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR),Target lesion revascularization (TLR) and target lesion failure (TLF) rates
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 posted11 Sep 2019
- Study start13 Nov 2019
- Primary completion31 Aug 2022
- Study completion3 Sep 2024
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 Chinese Patients Treated With Agent DCBStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085445
- Sponsor's protocol ID
- S2460
- Status last verified
- Dec 2025
- First submitted
- 9 Sep 2019
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lu TM, Jen HL, Ho HH, Lu CR, Tsai CT, Kuo FY, Lam SC, Wang JH, Livingston J, Cavalcante R, Kao HL. Paclitaxel-Coated Balloon for Coronary In-Stent Restenosis and De Novo Disease in Chinese Patients. JACC Asia. 2026 Jul 27:S2772-3747(26)00437-0. doi: 10.1016/j.jacasi.2026.06.008. Online ahead of print.
PubMed 42541503
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agent DCB Registry
- ClinicalTrials.gov ID
- NCT04085445
- Acronym / sponsor ID
- S2460
- Conditions
- Chinese Patients Treated With Agent DCB
- Keywords
- Agent DCB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 11 Sep 2019 (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.
To compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients.
Detailed description
The Agent DCB Registry study will enroll 500 subjects at up to 10 investigational sites in Taiwan, Hong-Kong and Singapore.
If participants decide to participate in this study, participants will first be asked to sign and date this consent form. If participants sign the consent form, participants will go through a baseline/ procedure process. Information about participants and participants' health will be collected and participants will have a limited physical examination.
Participants will need to have the laboratory tests (including myocardial enzyme test before and post the index procedure, pregnancy test before the index procedure) and other assessments to find out if participants meet the requirements to be in the study and to ensure it is safe for participants to have the procedure. These tests and assessments are part of routine care and may be done even if participants do not join the study. If participants have had some of them recently, they may not need to be repeated.
Participants will be expected to follow the scheduled follow-ups which occur at 30 days, 6 and 12 months, and then annually through 3 years post the index procedure for all enrolled subjects. Angiographic follow-up will perform at 9 months post index procedure for all the subjects with small vessel lesions and the first 100 consecutively enrolled subjects with ISR lesions. Enrolled subjects with the failure of advancing Agent DCB across target lesion will be followed through hospital discharge following the initial attempted index procedure.
Participants' participation in the study will be completed after approximately 3 years.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All enrolled subjects will be eligible for evaluation. The inclusion and exclusion criteria for the Agent DCB Registry study are listed in the following sections.
Key inclusion criteria (6 listed)
- Chinese subject at least 18 years of age(or meet age requirements per local law).
- Subject (or legal guardian) who understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Subject who has ischemic symptoms or evidence of myocardial ischemia and is clinically indicated for PCI and will be treated with Agent DCB.
- Subject is willing to comply with all protocol-required follow-up evaluation.
- In women with childbearing potential a negative pregnancy test is mandatory.
Key exclusion criteria (1 listed)
- Exclusion criteria are not required in the Agent DCB registry study as it is an "all comers" 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 |
|---|---|---|
| AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon CatheterTo compile the real-world clinical outcome data for the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter (Agent DCB) used in percutaneous coronary intervention (PCI) in Chinese patients. | Device | – |
Primary outcome
Number of Participants with 12 months post index procedure
Time frame: 12 months
Major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI, Q-wave and non-Q-wave) and target vessel revascularization (TVR),Target lesion revascularization (TLR) and target lesion failure (TLF) rates
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 Dec 2025.
- Derived from this study: PubMed 42541503Lu TM, Jen HL, Ho HH, Lu CR, Tsai CT, Kuo FY, Lam SC, Wang JH, Livingston J, Cavalcante R, Kao HL. Paclitaxel-Coated Balloon for Coronary In-Stent Restenosis and De Novo Disease in Chinese Patients. JACC Asia. 2026 Jul 27:S2772-3747(26)00437-0. doi: 10.1016/j.jacasi.2026.06.008. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chinese Patients Treated With Agent DCB, run by Boston Scientific Corporation at 9 sites in 3 countries.
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 6 inclusion and 1 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan, Hong Kong, Singapore. 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?
Number of Participants with 12 months post index procedure (time frame: 12 months). 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 NCT04085445, 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 Dec 2025.