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

Phase 3

Recruiting

• Conditions: acute myocardial infarction; 10011082

• Registration Number: NL-OMON41152
• Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 120

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
• Planned major surgery within 6 weeks
• Stent implantation < 1 month prior to inclusion
• Expected mortality from any cause within the next 12 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is fractional flow reserve (FFR) at 9 months angiographic<br /><br>follow-up. FFR is the ratio of mean coronary pressure distal of the treated<br /><br>lesion to mean aortic pressure during maximum hyperemia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Angiographic endpoints:<br /><br>- Instantaneous wave-free ratio (iFR)<br /><br>- TIMI coronary flow<br /><br>- laesion specific aspects<br /><br><br /><br>STsegment resolution on ECG<br /><br><br /><br>Clinical endpoints<br /><br>- MACE: major adverse coronary events, such as cardiac death, recurrent<br /><br>myocardial infarction in treated vessel, recurrent revasularization of<br /><br>infarct-related laesion<br /><br>- stent thrombosis<br /><br>- major bleedings </p><br>