Clinical trial NCT01124942: MGuard Stent in ST-elevation Myocardial Infarction
Official title: MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ST-elevation Myocardial Infarction
Thrombus
Stents
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with Myocardial Perfusional Blush Grade 2-3
timeFrame: 30 minutes after revascularization
Secondary outcomes:
measure: Number of MACE
timeFrame: 1 month
measure: Complete ST-segment resolution
timeFrame: 60 minutes after revascularization
measure: Thrombolysis in myocardial infarction antegrade coronary flow
timeFrame: 30 minutes after revascularization
measure: Corrected TIMI Frame count
timeFrame: 30 minutes after revascularization
measure: Infarct related area reduction and left ventricular ejection fraction recovery
timeFrame: 6 months
measure: Procedural device performance
timeFrame: 60 minutes after revascularizationl
measure: Number of MACE
timeFrame: 6 months
measure: Number of MACE
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University of Naples
Study officials:
affiliation: Federico II University of Naples
name: Federico Piscione, Associate Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.