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Safety and Efficacy Study of MGuard Stent After a Heart Attack

NCT01368471 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 433

Last updated 2013-05-29

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • InspireMD

    lead INDUSTRY

Principal Investigators

  • Alexandre Abizaid, MD, PhD · Inst Dante Pazzanese of Cardiology, Brazil

  • Dariusz Dudek, MD, PhD · Cardiac Catheterization Laboratories, Krakow, Poland

  • Sigmund Silber, MD, PhD · Heart Center at the Isar Academic Teaching Site of the University of Munich

  • Gregg Stone, MD · Columbia University Medical Center The Cardiovascular Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Poland
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01368471 on ClinicalTrials.gov