Status:
COMPLETED
An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chinese Patients Treated With Agent DCB
Eligibility:
All Genders
18+ years
Brief 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.
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 firs...
Eligibility Criteria
Inclusion
- 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
- \- Exclusion criteria are not required in the Agent DCB registry study as it is an "all comers" study.
Key Trial Info
Start Date :
November 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04085445
Start Date
November 13 2019
End Date
September 3 2024
Last Update
December 17 2025
Active Locations (9)
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1
Queen Mary Hospital
Hong Kong, Hong Kong
2
Tan Tock Seng Hospital
Singapore, Singapore
3
Hualien Tzu Chi Hospital
Hualien City, Taiwan, 970
4
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan