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New registry tracks Drug-Coated Balloon's Real-World performance in chinese heart patients

NCT ID NCT04085445

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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

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

  • China Medical University Hospital

    Taichung, Taiwan

  • Hualien Tzu Chi Hospital

    Hualien City, 970, Taiwan

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, Taiwan

  • Mackay Memorial Hospital

    Taipei, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tan Tock Seng Hospital

    Singapore, Singapore

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