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

Summary

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Eligibility

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.

Conditions4

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