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Can a Drug-Coated balloon beat a stent for tough heart attacks?

NCT ID NCT07806370

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This study looks back at medical records of heart attack patients with a large clot in a coronary artery. It compares two ways to reopen the blocked artery during emergency angioplasty: a drug-coated balloon that delivers medication and is then removed, versus a drug-eluting stent that stays in place as a permanent scaffold. The main question is whether the balloon approach reduces the risk of slow or no blood flow immediately after the procedure. Researchers will also track deaths, repeat heart attacks, strokes, and repeat procedures over one year.

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 (DCB) versus drug-eluting stent (DES) during emergency angioplasty for heart attack
What this could lead to
If drug-coated balloons work as well as stents, they might offer a way to open blocked heart arteries without leaving a permanent metal scaffold, potentially reducing long-term complications.
What could go wrong
This is a retrospective review of past records, not a controlled experiment, so results may be influenced by unmeasured factors. The findings will need confirmation in prospective trials.

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

About 668 people

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

Started

Jan 2019

Expected to finish

Jan 2028

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.

Who is studied

This is a single-center retrospective observational study. The study population consists of patients diagnosed with ST-elevation myocardial infarction (STEMI) with high thrombus burden (angiographic thrombus grade G2-G4) who underwent emergency percutaneous coronary intervention (PCI) at Xijing Hospital between January 1, 2019 and June 30, 2025. Eligible patients received either drug-coated balloon (DCB) or drug-eluting stent (DES) as the final revascularization strategy for the culprit vessel. Patients are identified from in-hospital medical records and coronary angiographic databases.

Ages

18 to 75 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: 1. Patients diagnosed with ST-elevation myocardial infarction (STEMI) undergoing emergency percutaneous coronary intervention (PCI) at this center: * Symptom onset ≤ 12 hours; OR * Symptom onset \> 12 hours with persistent ischemic symptoms. 2. Angiographic thrombus grade of the culprit vessel is G2-G4. 3. Reference vessel diameter of the culprit vessel: 2.25-4.0 mm. 4. Complete pre-procedural and post-procedural coronary angiographic imaging data are available. 5. Age ≥ 18 years old. Exclusion Criteria: 1. Participation in other clinical trials. 2. Cardiogenic shock or post-cardiac-arrest resuscitation state. 3. Multi-vessel coronary artery disease. 4. Severe calcified lesions requiring rotational atherectomy or shock-wave therapy. 5. Only compliant or non-compliant plain balloon dilation performed. 6. Both DES and DCB applied to the same culprit vessel. 7. Culprit lesion located in a coronary bypass graft, or in-stent restenosis / in-stent thrombosis. 8. Missing key angiographic or clinical follow-up data.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome ST-elevation myocardial infarction

As listed by the trial registrant

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

Acute coronary syndromes (ACS) ST elevation myocardial infarction (stemi)

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

  • First Affiliated Hospital of Fourth Military Medical University

    RECRUITING

    Xi'an, Shaanxi, 710032, China

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