New balloon treatment could change how heart attacks are treated

NCT ID NCT06742125

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests if a drug-coated balloon works as well as a drug-coated stent for people having a severe heart attack (STEMI). About 1,200 participants will receive either the balloon or the stent during emergency artery-opening procedures. The goal is to see if the balloon, which leaves no permanent implant behind, can reduce future heart problems and deaths.

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 1,244 people

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

Started

May 2025

Expected to finish

Jan 2032

An estimate. End dates often move.

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.

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: 1. . Age of Patients ≥18 years old; 2. Acute myocardial infarction patients with onset symptoms\<48 hours require emergency PCI; 3. . Diagnosis: Chest pain and other ischemic symptoms accompanied by ST segment elevation in at least two adjacent leads on electrocardiogram (① V2 or V3 lead: male\<40 years ≥ 0.25mV, ≥ 40 years ≥ 0.2mV; Female ≥1.5mV;② Other leads ≥ 1mV), or new left bundle branch block occurs; 4. Criminal blood vessels with clear requirements for emergency PCI; 5. Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length\<40mm; 6. After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection. 7. He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form. Exclusion Criteria: 1. The patient has allergies or contraindications to the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, Contrast Medias (Patients with clear contrast agent allergies such as rash but can be controlled with effective drugs such as glucocorticoids and diphenhydramine in advance can be selected); 2. The patient has active pathological bleeding; 3. History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia); 4. Patients who are pregnant or have the intention to become pregnant during the period of research; 5. Non cardiogenic combined lesions show an expected life expectancy of less than one year; 6. Left main trunk's stenosis ≥ 50% 7. History of coronary artery bypass grafting in the past; 8. Intubation or mechanical ventilation status; 9. . Cardiogenic Shock 10. . Without signature on informed consent

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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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, China

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