NCT01368471

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_4

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 29, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

February 17, 2011

Last Update Submit

May 28, 2013

Conditions

Myocardial Infarction

Keywords

STEMImyocardial infarctionstent

Outcome Measures

Primary Outcomes (1)

  • The incidence of complete ST segment resolution (defined as ≥70% ST 1. The incidence of complete ST segment resolution

    60 to 90 minutes after the last angiogram

Secondary Outcomes (2)

  • The incidence of Thrombolysis In Myocardial Infarction (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

    discharge, 30 days, 6 and 12 months post-procedure

Study Arms (2)

MGuard

EXPERIMENTAL

MGuard stent will be deployed

Device: MGuard

BMS or DES

ACTIVE COMPARATOR

A regular bare metal stent or drug-eluting stent will be deployed

Device: Control BMS or DES

Interventions

MGuardDEVICE

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.

MGuard
Control BMS or DESDEVICE

Control BMS or DES

BMS or DES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku

Bialystok, Poland

Location

Gilghsin: John Paul II Hospital

Krakow, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Oddział Kardiologii Inwazyjnej

Nowy Targ, Poland

Location

Centrum Kardiologii Inwazyjnej GVM Carint

Oświęcim, Poland

Location

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, Poland

Location

Milpark Hospital

Johannesburg, South Africa

Location

Related Publications (3)

  • Dudek D, Dziewierz A, Brener SJ, Abizaid A, Merkely B, Costa RA, Bar E, Rakowski T, Kornowski R, Dressler O, Abizaid A, Silber S, Stone GW. Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001484. doi: 10.1161/CIRCINTERVENTIONS.114.001484.

    PMID: 25603802DERIVED

  • Dudek D, Brener SJ, Rakowski T, Dziewierz A, Abizaid A, Silber S, Yaacoby E, Dizon JM, Costa RA, Maehara A, Dressler O, Stone GW. Efficacy of an Embolic Protection Stent as a Function of Delay to Reperfusion in ST-Segment Elevation Myocardial Infarction (from the MASTER Trial). Am J Cardiol. 2014 Nov 15;114(10):1485-9. doi: 10.1016/j.amjcard.2014.08.007. Epub 2014 Aug 27.

    PMID: 25277335DERIVED

  • Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyla R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004.

    PMID: 23103033DERIVED

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Gregg Stone, MD

    Columbia University Medical Center The Cardiovascular Research Foundation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

June 8, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 29, 2013

Record last verified: 2013-05

Locations

ZA(1)PL(6)