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Balloon over stent? new study tests Drug-Coated option for heart disease

NCT ID NCT05133921

Disease control Sponsor: Xijing Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether a drug-coated balloon (DCB) can safely treat blocked heart arteries, possibly avoiding the need for a permanent stent. Researchers followed 2487 patients who received the balloon instead of a stent. The goal was to see how well the balloon prevents heart-related deaths, heart attacks, and the need for repeat procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-coated balloon (paclitaxel)
What this could lead to
If successful, this could show that a drug-coated balloon is a safe and effective alternative to stents for some people with blocked heart arteries.
What could go wrong
This is a single-center, observational study, not a large randomized trial. The balloon can cause complications like artery tearing or sudden blockage, and results may not apply to all patients.

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

2,487 people

The number who actually took part.

Started

Dec 2015

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 patients who received PCI with one or more drug-coated balloons (DCB) in the Xijing hospital of the Air Force Medical University from December 1, 2015 to December 1, 2019.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients who received PCI with one or more drug-coated balloons (DCB) 2. Patients who did not received drug-eluting stent implantation Exclusion Criteria: 1\. Currently participating in another trial or participants unable to comply to follow-up

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Angioplasty, balloon Coronary heart disease

Contacts and locations

Locations

  • Ling Tao

    Xi'an, Shannxi, 710032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.