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Heart artery showdown: balloon or stent for big vessels?

NCT ID NCT06448637

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Updated 2 times

Summary

This study looks at two ways to treat blocked large heart arteries (≥3.5 mm) in people with coronary artery disease. One method uses a drug-coated balloon, the other a drug-releasing stent. The goal is to see which helps the artery relax and function better 8 months after treatment. About 94 adults will take part.

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 94 people

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

Started

Oct 2024

Expected to finish

Dec 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 who meet all of the following conditions are included. * Patients aged ≥ 18 years and; * Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and; * Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and; * Patients who have been informed of the characteristics of the study and have provided their written informed consent. Exclusion Criteria: Patients who meet at least one of the following conditions are excluded: * Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG). * Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery. * Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion. * Patients who received a combination of DES and DCB in the same vessel * Patients with glomerular filtration rate \<30 ml/min/ 1.73 m2 * Patients with body mass index \>35 (may affect the evaluation qualitative diameter of the coronary artery). * Patients with symptomatic congestive heart failure. * Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids). * Patients with heart transplant. * Patients with anemia (Hb \<12 g/dL in men and \<10 g/dL in women). * Patients, women of childbearing age with a positive pregnancy test. * Pregnant female patients. * Patients included in other clinical trials with active follow-up.

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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 places running it

    8 sites. 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 Provincial de Pontevedra

    RECRUITING

    Pontevedra, 36071, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari de Tarragona Joan XXIII

    RECRUITING

    Tarragona, 43005, Spain

  • Hospital Universitario Central de Asturias

    RECRUITING

    Oviedo, 33011, Spain

  • Hospital Universitario Juan Ramón Jiménez

    RECRUITING

    Huelva, 21005, Spain

  • Hospital Universitario Lucus Augusti

    RECRUITING

    Lugo, 270003, Spain

  • Hospital Universitario de Cabueñes

    RECRUITING

    Gijón, 33394, Spain

  • Hospital Universitario de Leon

    RECRUITING

    León, 24008, Spain

More trials for these conditions

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