New registry tracks Drug-Coated Balloon's Real-World performance in chinese heart patients
NCT ID NCT04085445
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed registry study followed 500 Chinese patients who received the Agent DCB, a paclitaxel-coated balloon catheter, during a heart procedure to open blocked arteries. The goal was to collect real-world data on heart-related events like heart attacks or repeat procedures over 12 months. The study did not test a new treatment but rather observed outcomes in routine practice.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel-coated balloon catheter
- What this could lead to
- If successful, this registry could provide real-world evidence on how well the Agent DCB balloon works for treating blocked heart arteries in Chinese patients.
- What could go wrong
- This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may not apply to other populations or devices.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
500 people
The number who actually took part.
- Started
-
Nov 2019
- Finished
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Sep 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 are not required in the Agent DCB registry study as it is an "all comers" study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cheng Hsin General Hospital
Taipei, Taiwan
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China Medical University Hospital
Taichung, Taiwan
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Hualien Tzu Chi Hospital
Hualien City, 970, Taiwan
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Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
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Mackay Memorial Hospital
Taipei, Taiwan
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National Taiwan University Hospital
Taipei, Taiwan
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Queen Mary Hospital
Hong Kong, Hong Kong
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Taipei Veterans General Hospital
Taipei, Taiwan
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Tan Tock Seng Hospital
Singapore, Singapore
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