NCT01368471

Safety and Efficacy Study of MGuard Stent After a Heart Attack

MASTER: MGUARD for Acute ST Elevation Reperfusion

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: InspireMD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	MGuard	MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.
DEVICE	Control BMS or DES	Control BMS or DES

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-06-08
• Last updated: 2013-05-29

Locations

7 sites across 2 countries: Poland, South Africa