MGuard Stent in ST-elevation Myocardial Infarction (GUARDIAN)
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|ClinicalTrials.gov Identifier: NCT01124942|
Recruitment Status : Unknown
Verified April 2010 by Federico II University.
Recruitment status was: Recruiting
First Posted : May 18, 2010
Last Update Posted : May 18, 2010
|Condition or disease||Intervention/treatment||Phase|
|ST-Elevation Myocardial Infarction Thrombus Stents||Device: MGuard net protective coronary stent Device: Bare-metal stent and manual thrombectomy device||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2011|
|Estimated Study Completion Date :||March 2013|
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 Name: 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
- Number of patients with Myocardial Perfusional Blush Grade 2-3 [ Time Frame: 30 minutes after revascularization ]Myocardial Perfusional Blush Grade 2-3 at the end of the procedure
- Number of MACE [ Time Frame: 1 month ]Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
- Complete ST-segment resolution [ Time Frame: 60 minutes after revascularization ]Complete (>70%) ST-segment resolution at 60 minutes post-revascularization
- Thrombolysis in myocardial infarction antegrade coronary flow [ Time Frame: 30 minutes after revascularization ]TIMI coronary flow at the end of the procedure
- Corrected TIMI Frame count [ Time Frame: 30 minutes after revascularization ]Corrected TIMI Frame count at the end of the procedure
- Infarct related area reduction and left ventricular ejection fraction recovery [ Time Frame: 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 [ Time Frame: 60 minutes after revascularizationl ]Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability
- Number of MACE [ Time Frame: 6 months ]Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
- Number of MACE [ Time Frame: 12 months ]Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124942
|Contact: Giovanni Esposito, MD||0817462216 ext firstname.lastname@example.org|
|Federico II University of Naples||Recruiting|
|Naples, Italy, 80131|
|Contact: Giovanni Esposito, MD 0817462216 ext 0039 email@example.com|
|Principal Investigator: Giovanni Esposito, MD PhD|
|Principal Investigator: Federico Piscione, Associate Professor|
|Study Chair:||Federico Piscione, Associate Professor||Federico II University of Naples|