New balloon treatment could change how heart attacks are treated
NCT ID NCT06742125
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
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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
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About 1,244 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Jan 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 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.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a diabetes drug shield the heart during a heart attack procedure?
- Blood condition may predict worse outcomes after heart attack
- Heart attack drug trial halted: could quick cholesterol drop save hearts?
- New balloon treatment could rival standard stent for heart attacks