Revascularization with paclitaxel-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarction - a randomized controlled trial - REVELATIO

Onze Lieve Vrouwe Gasthuis0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年4月23日

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•All patients presenting with an acute ST-elevation myocardial infarction and suitable for primary percutaneous coronary intervention(PPCI). The protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit lesion before inclusion.;Acute myocardial infarction eligible for PPCI:
•> 20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ECG or echocardiography)
•reperfusion is expected to be feasible within 12 hours after onset of complaints
•Infarct related artery eligible for PPCI and:
•De novo lesion in a native coronary artery
•Reference-vessel diameter >= 2.5mm and <= 4mm
•Without severe calcification
•Without diameter stenosis of >50% (by visual assessment) after thrombus aspiration and pre-dilatation.

•Age < 18 years and > 75 years
•History of myocardial infarction
•Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor.
•Participation in another clinical study, interfering with this protocol
•Uncertain neurological outcome e.g. resuscitation
•Intubation/ventilation
•Cardiogenic shock prior to randomization
•Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA < 6 months prior to inclusion or ischemic CVA with permanent neurological deficit)
•Gastro-intestinal / urinary tract bleeding < 2 months prior to inclusion
•Refusal to receive blood transfusion
•Planned major surgery within 6 weeks
•Stent implantation < 1 month prior to inclusion
•Expected mortality from any cause within the next 12 months

发起方

Onze Lieve Vrouwe Gasthuis