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Stenting unstable plaques: a new way to prevent second heart attacks?

NCT ID NCT05599061

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study looks at 600 people who had a major heart attack and have other narrowings in their heart arteries that are not severe but look unstable. Half will get a stent plus medication, and half will get medication alone. The goal is to see if stenting these unstable plaques reduces the chance of another heart attack or death.

What this could mean

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

Active substance
Percutaneous coronary intervention (stenting) plus optimal medical treatment
What this could lead to
If it works, this could show that stenting unstable plaques in heart attack patients lowers the risk of future heart attacks or death.
What could go wrong
This is an early-stage trial with 600 participants, so results may not apply to everyone. Stenting carries risks like bleeding or vessel damage, and the benefit over medication alone is not yet proven.

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

609 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Dec 2028

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 \> 18 years. * Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (\> 1mm in \> 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads) in the first 72 hours of the symptom's onset. * Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (\>24 hours and \<60 days after PCI of the culprit lesion). * Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ). * Subject agrees to not participate in any other clinical trial study for a period of 4 years following the inclusion in the study. * Informed consent signed. Exclusion Criteria: * Inability to provide informed consent. * Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy. * Known intolerance to aspirin, heparin, everolimus, contrast material. * Unresolved mechanical complication or cardiogenic shock at the staged procedure. * Non-culprit study lesions located in the left main coronary artery or in coronary vessels with prior coronary revascularization (PCI or by-pass) or with distal vessel occlusion. * Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation. * Asthma or known history of bronchial hyper-reactivity. * Chronic renal dysfunction with creatinine clearance \< 45 ml/min. * Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy \< 4 years. * Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Coronary Disease myocardial ischemia ST-elevation myocardial infarction

As listed by the trial registrant

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

Coronary artery disease Coronary disease Ischemic heart disease

Contacts and locations

Locations

  • Chu de Toledo

    Guadalajara, Spain

  • H.I.U. Materno Infantil de Las Palmas

    Las Palmas de Gran Canaria, 35016, Spain

  • H.U. de Gran Canaria-Dr. Negrin

    Las Palmas de Gran Canaria, 35010, Spain

  • Hospital Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003, Spain

  • Hospital Del Mar

    Barcelona, 08003, Spain

  • Hospital General Universitario Dr.Balmis

    Alicante, 03010, Spain

  • Hospital General Universitario de Albacete

    Albacete, 02006, Spain

  • Hospital General Universitario de Castellón

    Castellon, 12004, Spain

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005, Spain

  • Hospital General Universitario de Elche

    Elche, 03203, Spain

  • Hospital General Universitario de Valencia

    Valencia, 46014, Spain

  • Hospital La Princesa

    Madrid, 28006, Spain

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitari Joan Xxiii

    Tarragona, 43005, Spain

  • Hospital Universitari Miquel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitari MútuaTerrassa

    Terrassa, 08221, Spain

  • Hospital Universitari Sant Joan D'Alacant

    Alicante, 03550, Spain

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120, Spain

  • Hospital Universitari Vall Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitario 12 Octubre

    Usera, 28041, Spain

  • Hospital Universitario A Coruña

    A Coruña, 15006, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Universitario Gregorio Marañon

    Madrid, 28007, Spain

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario Nuestra Señora de La Candelaria

    Santa Cruz de Tenerife, 38010, Spain

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009, Spain

  • Hospital Universitario Puerta de Hierro

    Majadahonda, 28222, Spain

  • Hospital Universitario Reina Sofia de Cordoba

    Córdoba, 14004, Spain

  • Hospital Universitario San Cecilio

    Granada, 18016, Spain

  • Hospital Universitario Virgen Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Cabueñes

    Gijón, 33394, Spain

  • Hospital Universitario de Donostia

    San Sebastián, 20014, Spain

  • Hospital Universitario de Girona Dr Trueta

    Girona, 17007, Spain

  • Hospital Universitario de Leon

    León, 24001, Spain

  • Hospital Universitario de Navarra

    Pamplona, 31008, Spain

  • Hospital Universitario de Torrevieja

    Torrevieja, 03186, Spain

  • Hospital de Manises

    Manises, 46940, Spain

  • Hospital de Merida

    Mérida, 06800, Spain

  • Hospital de Santa Creu I Sant Pau

    Barcelona, 08025, Spain

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