An "All-Comers" Study of the AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter Used in Real-World Clinical Practice in Chinese Patients

2019-09-17 02:47:45 | BioPortfolio


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.


The Agent DCB Registry study will enroll 500 subjects at up to 10 investigational sites in Taiwan and Singapore.

If you decide to participate in this study, you will first be asked to sign and date this consent form. If you sign the consent form, you will go through a baseline/ procedure process. Information about you and your health will be collected and you will have a limited physical examination.

You 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 you meet the requirements to be in the study and to ensure it is safe for you to have the procedure. These tests and assessments are part of routine care and may be done even if you do not join the study. If you have had some of them recently, they may not need to be repeated.

You 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.

Your participation in the study will be completed after approximately 3 years.

Study Design


This Study Will Evaluate the Real-world Long-term Clinical Outcome in Chinese Patients Treated With Agent DCB


AgentTM MONORAILTM Paclitaxel-Coated PTCA Balloon Catheter


Not yet recruiting


Boston Scientific Corporation

Results (where available)

View Results


Published on BioPortfolio: 2019-09-17T02:47:45-0400

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