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MGuard Stent in ST-elevation Myocardial Infarction

NCT01124942 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2022-03-31

No results posted yet for this study

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.

Conditions

  • ST-elevation Myocardial Infarction
  • Thrombus
  • Stents

Interventions

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.

DEVICE

Bare-metal stent and manual thrombectomy device

Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Principal Investigators

  • Federico Piscione, Associate Professor · Federico II University of Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-01
Primary Completion
2011-03-01
Completion
2013-03-01

Countries

  • Italy

Study Locations

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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 NCT01124942 on ClinicalTrials.gov