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Treatment for vulnerable plaques in heart patients with multiple artery blockages

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

Not applicable Interventional Fundación EPIC · NCT05599061

This study is testing whether combining a heart procedure with medication can help patients with multiple blocked arteries and heart attacks avoid serious problems better than just taking medication alone.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment600 (estimated)
Ages18 Years and up
SexAll
SponsorFundación EPIC Academic / other
Locations49 sites (L'Hospitalet de Llobregat, Barcelona and 48 other locations)
Trial IDNCT05599061 on ClinicalTrials.gov

What this trial studies

This study compares a preventive approach using percutaneous coronary intervention (PCI) combined with optimal medical treatment (OMT) against OMT alone for patients with ST-elevation myocardial infarction (STEMI) and multivessel coronary disease. Patients with intermediate lesions will undergo fractional flow reserve (FFR) testing, and those with FFR values above 0.80 will be assessed using optical coherence tomography (OCT) to identify vulnerable plaques. If vulnerable plaques are found, patients will be randomized to receive PCI with stent implantation plus OMT or OMT alone. The goal is to determine the effectiveness of PCI in preventing adverse outcomes in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with STEMI and multivessel coronary disease who have non-culprit lesions suitable for functional assessment.

Not a fit: Patients with FFR values of 0.80 or lower, indicating they do not have non-functionally significant lesions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of future heart events in patients with vulnerable plaques.

How similar studies have performed: While there have been studies on PCI and vulnerable plaques, this specific approach combining FFR and OCT in STEMI patients is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

L'Hospitalet de Llobregat, Barcelona and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseCoronary DiseaseIschemic Heart DiseaseVulnerable PlaqueOptical Coherence TomographyFractional Flow Reserve and ST-elevation Myocardial Infarction
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.