Stents Clinical Trial - MGuard Stent in ST-elevation Myocardial Infarction

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
ST-elevation Myocardial Infarction
Stents
Thrombus

Clinical Trial Details

NCT number	NCT01124942
Study type	Interventional
Source	Federico II University
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2010
Completion date	March 1, 2013

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

MGuard Stent in ST-elevation Myocardial Infarction — GUARDIAN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms