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New study tests which balloon best heals heart arteries after a heart attack

NCT ID NCT07514988

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study compares two types of drug-coated balloons used to open blocked heart arteries in people with acute coronary syndrome (a serious heart condition). About 60 adults will receive either a sirolimus-coated or paclitaxel-coated balloon. The main goal is to see which balloon leads to better artery healing and less inflammation 3 months after the procedure.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

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: Subjects must meet all of the following criteria to be enrolled: 1. Age between 18 and 80 years old, both genders eligible; 2. Coronary angiography showing non-complex lesions with acute coronary syndrome (non-ST-elevation myocardial infarction and unstable angina) deemed suitable for drug-coated balloon treatment by the investigator; 3. Visually estimated lesion length ≤28mm, visually estimated vessel diameter ≥2.5mm and ≤3.0mm; 4. Successful lesion pre-dilation (must simultaneously meet all 3 criteria: no Type C or greater dissection; TIMI flow grade 3; visually estimated residual stenosis ≤30%); 5. Able to understand the study purpose, willing to complete follow-up visits, and voluntarily provide informed consent. Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: 1. Total occlusion (TIMI 0 flow) lesion; 2. In-stent restenosis lesion; 3. Concurrent left main disease or severe three-vessel disease requiring coronary artery bypass grafting; 4. Target lesion with severe calcification or tortuosity that cannot be crossed by guidewire; 5. Coronary artery bypass graft stenosis; 6. Confirmed ST-elevation myocardial infarction; 7. Cardiogenic shock or requiring mechanical respiratory and circulatory support; 8. Hemodynamically unstable tachyarrhythmia or bradyarrhythmia; 9. Severe renal insufficiency or undergoing hemodialysis; 10. Known allergy or intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media, paclitaxel, sirolimus and/or other analogues; 11. Systemic lupus erythematosus or other systemic autoimmune diseases; 12. History of stroke within 6 months prior to enrollment; 13. Scheduled elective surgery within 6 months after enrollment requiring discontinuation of anticoagulant or antiplatelet medications; 14. Currently participating in other drug or interventional medical device clinical studies; 15. Other conditions deemed unsuitable for enrollment by the investigator.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fuwai hospital, CAMS&PUMC

    Beijing, Beijing Municipality, 100037, China

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