Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Balloon vs stent: which works best for Rock-Hard heart plaques?

NCT ID NCT06657833

Disease control Sponsor: Fundación EPIC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests two ways to treat hardened calcium deposits in heart arteries. After using sound waves to break up the calcium, doctors will either place a drug-coated balloon or a drug-coated stent. The trial will follow 128 patients for 9 months to see which approach keeps arteries open better and has fewer complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-eluting balloon or drug-eluting stent
What this could lead to
If successful, this could show that balloons work as well as stents for tough calcium deposits, offering a simpler option for some heart patients.
What could go wrong
This is a mid-sized trial (128 people) and results may not apply to all patients. The study is not blinded, so bias is possible. Risks include vessel injury or blockage.

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 128 people

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

Started

Dec 2024

Expected to finish

Oct 2027

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: Patients must meet all inclusion criteria: * Patients \>18 years admitted for stable coronary artery disease or acute coronary syndromes and indication for percutaneous coronary intervention (PCI) and * Severe coronary lesion with calcified nodule, confirmed with intracoronary imaging (optical coherence tomography or intravascular ultrasound) and; * Lesion to treat in a vessel between 2.5 and 4 mm. Exclusion Criteria: Patients must not meet any criteria * Inability to provide oral and written informed consent or unwillingness to come back for systematic angiographic follow-up. * Pregnant or breastfeeding patients. * Cardiogenic Shock or Cardiac arrest at the moment of the index procedure. * Impossibility to maintain double antiplatelet treatment during at least 1 month. * Life expectancy \<1 year. * Index lesion at left main stem. * Aorto-ostial lesion. * Target lesion previously treated with stents or DEB. * High thrombus burden in the target lesion (TIMI thrombus scale≥3).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Coronary artery disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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 places running it

    14 sites in 2 countries. 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

  • Hospital Clínico San Carlos

    RECRUITING

    Moncloa-Aravaca, 28040, Spain

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, 47003, Spain

  • Hospital Del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Hospital General Universitario de Valencia

    RECRUITING

    Valencia, 46014, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Madrid, 28222, Spain

  • Hospital Universitario de Galdakao-Usansolo

    RECRUITING

    Galdakao, 48960, Spain

  • Hospital Universitario de La Paz

    RECRUITING

    Fuencarral-El Pardo, 28046, Spain

  • Hospital Universitario de León

    RECRUITING

    León, 24008, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital Universitario de Vigo

    RECRUITING

    Vigo, 36312, Spain

  • Hospital Universitario y Politécnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

More trials for these conditions

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