Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
350 participants
INTERVENTIONAL
2010-03-01
2013-03-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MGuard
MGuard net protective stent, investigational 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.
BMS plus thrombectomy
Bare-metal stent plus manual thrombectomy device
Bare-metal stent and manual thrombectomy device
Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent
Interventions
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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.
Bare-metal stent and manual thrombectomy device
Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Giovanni Esposito
Cardiologist
Principal Investigators
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Federico Piscione, Associate Professor
Role: STUDY_CHAIR
Federico II University of Naples
Locations
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Federico II University of Naples
Naples, , Italy
Countries
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References
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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.
Other Identifiers
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NA116/09
Identifier Type: -
Identifier Source: org_study_id
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