MGuard Stent in ST-elevation Myocardial Infarction (GUARDIAN)

MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: ST-elevation Myocardial Infarction; Thrombus; Stents
• Intervention / Treatment: Device: MGuard net protective coronary stent; Device: Bare-metal stent and manual thrombectomy device

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 Type: Interventional
• Enrollment (Actual): 350
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University of Naples

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MGuard; MGuard net protective stent, investigational device	Device: MGuard net protective coronary stent; It is a new closed-cell design stent concept. with an ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, anchored to the external surface of the struts. This net (string diameter 10-22 μm) minimally affects 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.; Other Names: MGuard net protective stent
Active Comparator: BMS plus thrombectomy; Bare-metal stent plus manual thrombectomy device	Device: Bare-metal stent and manual thrombectomy device; Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Myocardial Perfusional Blush Grade 2-3	Myocardial Perfusional Blush Grade 2-3 at the end of the procedure	30 minutes after revascularization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of MACE	Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.	1 month
Complete ST-segment resolution	Complete (>70%) ST-segment resolution at 60 minutes post-revascularization	60 minutes after revascularization
Thrombolysis in myocardial infarction antegrade coronary flow	TIMI coronary flow at the end of the procedure	30 minutes after revascularization
Corrected TIMI Frame count	Corrected TIMI Frame count at the end of the procedure	30 minutes after revascularization
Infarct related area reduction and left ventricular ejection fraction recovery	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.	6 months
Procedural device performance	Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability	60 minutes after revascularizationl
Number of MACE	Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.	6 months
Number of MACE	Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.	12 months

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Study Chair: Federico Piscione, Associate Professor, Federico II University of Naples

Publications and helpful links

General Publications

• Piscione F, Danzi GB, Cassese S, Esposito G, Cirillo P, Galasso G, Rapacciuolo A, Leosco D, Briguori C, Varbella F, Tuccillo B, Chiariello M. Multicentre experience with MGuard net protective stent in ST-elevation myocardial infarction: safety, feasibility, and impact on myocardial reperfusion. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):715-21. doi: 10.1002/ccd.22292.
• Rapacciuolo A, D'andrea C, Maresca G, di Pietro E, Piscione F, Chiariello M. Multiple MGuard stent implantation to treat massive right coronary artery dissection during primary coronary angioplasty. J Cardiovasc Med (Hagerstown). 2011 May;12(5):356-60. doi: 10.2459/JCM.0b013e328334092d.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: April 8, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (Estimate): May 18, 2010

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: NA116/09