Status:
UNKNOWN
Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction
Lead Sponsor:
Onze Lieve Vrouwe Gasthuis
Collaborating Sponsors:
Biotronik SE & Co. KG
Volcano Corporation
Conditions:
Coronary Artery Disease
Acute Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous ...
Detailed Description
Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in primary percutaneous ...
Eligibility Criteria
Inclusion
- Acute myocardial infarction eligible for primary PCI:
- \> 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.
- The protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit lesion before inclusion.
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02219802
Start Date
August 1 2014
Last Update
August 19 2014
Active Locations (1)
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1
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands, 1091 AC