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

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41152

Enrollment

120

Registered

2014-06-11

Start date

2014-09-30

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute myocardial infarction

Interventions

All procedures will be performed by an interventional cardiologist. The use of thrombectomy or thrombosuction devices is recommended as a standard procedure in STEMI. Predilatation with a balloon is

Eligibility

Age

18 Years to 99 Years

Inclusion 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 50% (by visual assessment) after thrombus aspiration and pre-dilatation.

Exclusion criteria

Exclusion criteria: • Age 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

Design outcomes

Primary

Measure	Time frame
The primary endpoint is fractional flow reserve (FFR) at 9 months angiographic follow-up. FFR is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)