Safety and Efficacy Study of MGuard Stent After a Heart Attack (MASTER)

May 28, 2013 updated by: InspireMD

MASTER: MGUARD for Acute ST Elevation Reperfusion

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

433

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland
        • Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku
      • Krakow, Poland
        • Gilghsin: John Paul II Hospital
      • Krakow, Poland
        • Szpital Uniwersytecki w Krakowie
      • Nowy Targ, Poland
        • Oddział Kardiologii Inwazyjnej
      • Oświęcim, Poland
        • Centrum Kardiologii Inwazyjnej GVM Carint
      • Warsaw, Poland
        • Centralny Szpital Kliniczny MSWiA w Warszawie
  • South Africa
      • Johannesburg, South Africa
        • Milpark Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • 18 years of age
  • ST-segment elevation (more than 2mm in more than contiguous leads)
  • MI with symptom onset less than 12h
  • The patient is willing to comply with specified follow-up evaluations
  • Signed ICF
  • Single de novo lesion in the target (culprit) vessel
  • Target lesion maximum length is 33 mm (by visual estimation)
  • Reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation
  • Randomization should occur as soon as Presence of TIMI 2 or 3 before randomization Exclusion Criteria
  • Pregnant or nursing patients
  • Left Bundle Branch Block (LBBB), paced rhythm, or other Electrocardiogram (ECG) abnormality
  • Impaired renal function
  • Prior coronary artery bypass graft surgery
  • Bleeding diathesis
  • Contraindication to aspirin
  • cardiopulmonary resuscitation
  • Cardiogenic shock
  • chronic warfarin anticoagulation
  • LVEF less than 20%
  • other medical illness
  • participation in another investigational drug or device study that has not reached its primary endpoint
  • Left main coronary artery disease with 50% stenosis
  • Ostial target lesion
  • Failure to visualize vessel anatomy distal to the culprit lesion
  • Moderate to heavily calcified target lesion or vessel
  • excessive tortuosity
  • bifurcation with a side branch more than 2.0 mm in diameter
  • A significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent
  • Diffuse disease distal to target lesion with impaired runoff
  • Any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion
  • PCI of another lesion performed within 6 months before the index procedure
  • Target lesion located in a saphenous vein graft

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MGuard
MGuard stent will be deployed
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.
Active Comparator: BMS or DES
A regular bare metal stent or drug-eluting stent will be deployed
Device: Control BMS or DES
Control BMS or DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution
Time Frame: 60 to 90 minutes after the last angiogram
60 to 90 minutes after the last angiogram

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.
Time Frame: 60-90 minutes after last angiogram
The incidence of TIMI 3 flow at the end of the procedure.
60-90 minutes after last angiogram
Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure
Time Frame: discharge, 30 days, 6 and 12 months post-procedure
Major Adverse Cardiac Events (MACE): defined as cardiac death, reinfarction (Q wave and non-Q wave), or repeat ischemia-driven target lesion revascularization (TLR) by percutaneous or surgical methods at hospital discharge, 30 days, 6 months and 1 year post-procedure.
discharge, 30 days, 6 and 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InspireMD

Investigators

  • Principal Investigator: Alexandre Abizaid, MD, PhD, Inst Dante Pazzanese of Cardiology, Brazil
  • Principal Investigator: Dariusz Dudek, MD, PhD, Cardiac Catheterization Laboratories, Krakow, Poland
  • Principal Investigator: Sigmund Silber, MD, PhD, Heart Center at the Isar Academic Teaching Site of the University of Munich
  • Study Chair: Gregg Stone, MD, Columbia University Medical Center The Cardiovascular Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

June 7, 2011

First Posted (Estimate)

June 8, 2011

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMD-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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