MGuard Stent in ST-elevation Myocardial Infarction

Not Applicable

Completed

• Conditions: ST-elevation Myocardial Infarction; Thrombus; Stents
• Interventions: Device: Bare-metal stent and manual thrombectomy device; Device: MGuard net protective coronary stent

• Registration Number: NCT01124942
• Lead Sponsor: Federico II University

Brief Summary

The Investigators will test the hypothesis that MGuard net protective stent, the investigational device, would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent percutaneous coronary interventions.

Detailed Description

Embolization of thrombotic debris still represents a complication for ST-elevation myocardial infarction (STEMI) patients undergoing percutaneous coronary interventions (PCI).

Distal embolization may decrease coronary and myocardial reperfusion after PCI in STEMI setting.

Unfortunately, intracoronary filters present several important limitations limiting their use and their efficacy especially in presence of huge amount of thrombus. In this respect, recent trials investigated whether a default manual thrombectomy strategy before stenting would ameliorate angiographic as well as clinical outcomes for STEMI patients undergoing percutaneous revascularization.

Of note, the most of embolization occurs when guidewire, and thrombectomy device cross the thrombus, and after the stent has been implanted as a consequence of plaque prolapse through the stent struts.

MGuard net protective stent, the investigational device, is a bare-metal stent covered with a ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, that is anchored to the external surface of the struts. This biocompatible fiber net (string diameter 10-22 μm) has minimal effects on the stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net and isolating the prothrombotic intima components from the blood stream.

This protocol will test the hypothesis that MGuard stent would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent PCI in terms of angiographic as well as clinical outcomes.

Study Timeline

• Study Start: 2010-03-01
• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Primary Completion: 2011-03-01
• Study Completion: 2013-03-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• >/= 18-year-old patients, willing to participate the study, after informed consent signature
• Female not pregnant or potentially child-bearing
• > 1 mV ST segment elevation in two or more contiguous leads
• Acute MI lasting more than 30 minutes and less than 12 hours
• De novo acute MI
• Infarct related artery reference vessel diameter >/= 2.5 mm
• Patient suitable for stenting according to vessel and lesion features

Exclusion Criteria

• Dual antiplatelet therapy contraindication
• Ischemic stroke less than 30 days or previous haemorrhagic stroke
• WBC count less than 1000 per mm3;
• Platelet count less than 50.000 per mm3
• Life expectancy less than 1 year
• Cardiogenic shock at admission
• Previous stented infarct related artery
• Stent thrombosis as the responsible for current STEMI
• Inability to identify infarct related artery
• True bifurcation lesion, or lesion near a side branch with a reference vessel diameter >/= 2.5 mm that could be diseased after stenting procedure
• LBBB
• Definitive pacing (or ECG abnormalities precluding ST-segment resolution evaluation
• Participation other study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS plus thrombectomy	Bare-metal stent and manual thrombectomy device	Bare-metal stent plus manual thrombectomy device
MGuard	MGuard net protective coronary stent	MGuard net protective stent, investigational device

Primary Outcome Measures

Name	Time	Method
Number of patients with Myocardial Perfusional Blush Grade 2-3	30 minutes after revascularization	Myocardial Perfusional Blush Grade 2-3 at the end of the procedure

Secondary Outcome Measures

Name	Time	Method
Number of MACE	12 months	Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
Complete ST-segment resolution	60 minutes after revascularization	Complete (\>70%) ST-segment resolution at 60 minutes post-revascularization
Thrombolysis in myocardial infarction antegrade coronary flow	30 minutes after revascularization	TIMI coronary flow at the end of the procedure
Corrected TIMI Frame count	30 minutes after revascularization	Corrected TIMI Frame count at the end of the procedure
Infarct related area reduction and left ventricular ejection fraction recovery	6 months	Six-month infarct related area reduction and left ventricular ejection fraction recovery as compared with infarct related area and and left ventricular ejection fraction at admission.
Procedural device performance	60 minutes after revascularizationl	Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability

Trial Locations

Locations (1)

Federico II University of Naples; 🇮🇹 Naples, Italy