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New balloon method may improve stent success in Rock-Hard arteries

NCT ID NCT04253171

Disease control Sponsor: Herlev and Gentofte Hospital 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a special balloon that uses sound waves to break up calcium (balloon lithoplasty) works better than standard balloons for preparing severely calcified coronary arteries before placing a stent. The trial involved 200 adults with stable heart disease or non-emergency heart attacks. The goal was to see if the new technique reduces procedure failures and heart-related problems within one year.

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

200 people

The number who actually took part.

Started

Jan 2020

Finished

Nov 2025

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 to 90 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: * Age ≥ 18 years and \< 90 years * Stable coronary heart disease or non-ST elevation acute coronary syndrome * PCI planned in severely calcified, non-occluded, de-novo lesion in native vessel. Definition of severe calcifications (minimum 1 of 3 (i-iii)); i. Angiography: Radioopacities of the vessel wall visible on cine images before contrast injection on both sides of the vessel lumen in more than one projection. ii. OCT (before lesion preparation): Maximum calcium 1) angle \>180 degrees AND 2) thickness 0.5mm, AND 3) longitudinal length \>5m m. iii. IVUS (before lesion preparation): Maximum calcium angle \>270 degrees. * Functional evidence of ischemia (non-invasive stress test or fractional flow reserve) in the target vessel territory or stenosis ≥ 90% by visual estimate * Target vessel reference diameter visually estimated at 2.5-4 mm with ability to pass a 0.014" guidewire across lesion * Ability to tolerate dual antiplatelet therapy * Informed consent Angiographic exclusion criteria: * Unprotected left main stenosis * Chronic total occlusion * Severely calcified bifurcated lesion with expected need to use two stent technique * Coronary artery dissection Clinical exclusion criteria * ST-segment elevation acute myocardial infarction * Planned later revascularization in non-study lesions * Planned cardiovascular intervention within 30 days after study intervention * Clinical instability including decompensated heart disease * Life expectancy of less than 1 year * Active peptid ulcer or upper gastrointestinal bleeding within 6 months * Ongoing systemic infection Paraclinical exclusion criteria * Left ventricular ejection fraction \<35 % * Renal function with eGFR \<30 mL/min * Pregnant or nursing

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis

As listed by the trial registrant

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

Coronary artery calcification Coronary artery disease Percutaneous coronary intervention

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9100, Denmark

  • Aarhus University Hospital Skejby

    Aarhus, 8200, Denmark

  • Gentofte University Hospital

    Gentofte Municipality, Copenhagen, 2900, Denmark

  • North-Estonia Medical Center

    Tallinn, Estonia

  • Odense University Hospital

    Odense, 5000, Denmark

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Trondheim University Hospital

    Trondheim, Norway

  • University Hospital Leuven

    Leuven, Belgium

  • Zealand University Hospital, Roskilde Sygehus

    Roskilde, 4000, Denmark

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