NL-OMON41152
Recruiting
Phase 3
Revascularization with paclitaxel-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarction - a randomized controlled trial - REVELATIO
Onze Lieve Vrouwe Gasthuis0 sites120 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- acute myocardial infarction
- Sponsor
- Onze Lieve Vrouwe Gasthuis
- Enrollment
- 120
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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