An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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.
EXCLUSION CRITERIA
Exclusion Criteria:
- Exclusion criteria are not required in the Agent DCB registry study as it is an "all comers" study.
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Chinese Patients Treated With Agent DCB
Age (in years)
18+
Participants needed
500
Est. Completion Date
Dec 31, 2024
Treatment type
Observational [Patient Registry]
Sponsor
Boston Scientific Corporation
ClinicalTrials.gov identifier
NCT04085445
Study number
S2460
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