Balloon vs. stent: new trial tests which is better for Rock-Hard arteries

NCT ID NCT07277114

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a drug-coated balloon works as well as a drug-eluting stent for people with severe calcium deposits in their heart arteries. After using special tools to break up the calcium, 656 participants will be randomly assigned to one of the two treatments. Researchers will track major heart problems like heart attacks or the need for 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) and drug-eluting stent (DES)
What this could lead to: If DCB works as well as DES, patients with severe calcium buildup may have a stent-free option that reduces long-term hardware in the artery.
What could go wrong: This is a mid-sized trial (656 people) testing a non-inferiority idea, so even if DCB is similar, it may not be better. Risks include artery injury, blockages, or heart events during or 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 656 people

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

Started

Feb 2026

Expected to finish

Dec 2030

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: * Age ≥ 18 years * Moderate to severe calcified lesions assessed by coronary angiography * In situ coronary artery calcification * Target lesion with indications for coronary intervention * Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm * Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA). * QFR \> 0.8 after calcification modification Exclusion Criteria: * Patients with ST-segment elevation myocardial infarction: * Patients with renal failure requiring dialysis or currently undergoing dialysis. * Patients whose coronary angiography quality is unsuitable for QFR analysis. * Patients with in-stent restenosis. ⑤ Patients with other medical conditions and a life expectancy of \<1 year. ⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy. ⑦ Patients who cannot tolerate dual antiplatelet therapy. ⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator. ⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol. ⑩ Patients currently participating in another clinical trial for coronary interventional devices.

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Conditions

The condition(s) this trial relates to.

coronary atherosclerosis

As listed by the trial registrant

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

Coronary calcification

How to take part

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

The places running it

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

Balloon vs. stent: new trial tests which is better for Rock-Hard arteries

What the study statuses mean