An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients
NCT ID: NCT04085445
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2019-11-13
2024-09-03
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Tan Tock Seng Hospital
Singapore, , Singapore
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Cheng Hsin General Hospital
Taipei, , Taiwan
Mackay Memorial Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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S2460
Identifier Type: -
Identifier Source: org_study_id