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Could a balloon replace stents for major heart artery clogs?

NCT ID NCT07548281

Disease control Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a drug-coated balloon (DCB) is as safe and effective as a drug-eluting stent (DES) for treating large blockages in heart arteries. About 2,492 patients will be randomly assigned to receive either a balloon or a stent, guided by advanced imaging. The goal is to see if the balloon can avoid leaving a permanent metal implant, potentially reducing bleeding risks.

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) and drug-eluting stent (DES)
What this could lead to
If successful, this could offer a stent-free option for treating large coronary artery blockages, potentially reducing long-term complications from permanent implants.
What could go wrong
This is a large but early-stage comparison trial. The balloon-only approach may not work as well as stents for all patients, and there are risks like vessel recoil or dissection.

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 2,492 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2033

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

19 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: 1. Patients must require PCI based on clinical condition (angiographic stenosis ≥ 75% or angiographic stenosis ≥ 50% with AngioFFR≤0.80) and have signed the informed consent form. 2. Coronary angiography shows a single non-left main lesion, with a reference vessel diameter between 2.75mm and 4.00mm, and an estimated lesion length \< 40mm. 3. Following adequate intraoperative lesion preparation, the following must be met: IVUS shows MLA≥ 4.0mm² and/or AnioFFR \> 0.80. 4. Absence of flow-limiting dissection or hematoma (angiographic Type A or B dissection; IVUS dissection not involving the media) and TIMI flow grade 3 5. Patients must be able to be followed up for more than 1 year and be willing to cooperate with the trial follow-up requirements. Exclusion Criteria: 1. Patients younger than 19 or older than 80 years of age. 2. High-Risk Clinical/Anatomical Factors: Cardiogenic shock, left main disease, severely tortuous lesions, complex bifurcation lesions, severe calcification, total occlusion of the target vessel, or bypass grafts. 3. Recent major surgery (within 1 month pre-procedure) or clear gastrointestinal bleeding events. 4. Known allergy or contraindication to heparin, aspirin, clopidogrel, prasugrel, ticagrelor, or contrast media (patients with clear contrast allergies such as rash may be included if controlled beforehand with effective medication like glucocorticoids or diphenhydramine). 5. Women who are currently pregnant or breastfeeding. 6. Non-cardiac comorbidities indicating an expected life expectancy of less than 1 year. 7. Any other factors that may affect follow-up or participation in other clinical studies.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

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