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

Korábbi kezelés

• 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.

Más betegség

• Asthma or known history of bronchial hyper-reactivity.

Laborértékek

• Chronic renal dysfunction with creatinine clearance < 45 ml/min.

Életkor

• Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
• Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy < 4 years.

Egyéb

• Inability to provide informed consent.
• Known intolerance to aspirin, heparin, everolimus, contrast material.
• Unresolved mechanical complication or cardiogenic shock at the staged procedure.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

• 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.