Back to results

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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

MGuard

Control BMS or DES

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring STEMI, myocardial infarction, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku
Gilghsin: John Paul II Hospital
Szpital Uniwersytecki w Krakowie
Oddział Kardiologii Inwazyjnej
Centrum Kardiologii Inwazyjnej GVM Carint
Centralny Szpital Kliniczny MSWiA w Warszawie
Milpark Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MGuard

BMS or DES

Arm Description

MGuard stent will be deployed

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.

The incidence of TIMI 3 flow at the end of the procedure.

Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months 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.

Full Information

NCT ID

NCT01368471

First Posted

February 17, 2011

Last Updated

May 28, 2013

Sponsor

InspireMD

1. Study Identification

Unique Protocol Identification Number

NCT01368471

Brief Title

Safety and Efficacy Study of MGuard Stent After a Heart Attack

Acronym

MASTER

Official Title

MASTER: MGUARD for Acute ST Elevation Reperfusion

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InspireMD

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

STEMI, myocardial infarction, stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

433 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MGuard

Arm Type

Experimental

Arm Description

MGuard stent will be deployed

Arm Title

BMS or DES

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

MGuard

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Control BMS or DES

Intervention Description

Control BMS or DES

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.

Description

The incidence of TIMI 3 flow at the end of the procedure.

Time Frame

60-90 minutes after last angiogram

Title

Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexandre Abizaid, MD, PhD

Organizational Affiliation

Inst Dante Pazzanese of Cardiology, Brazil

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dariusz Dudek, MD, PhD

Organizational Affiliation

Cardiac Catheterization Laboratories, Krakow, Poland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sigmund Silber, MD, PhD

Organizational Affiliation

Heart Center at the Isar Academic Teaching Site of the University of Munich

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gregg Stone, MD

Organizational Affiliation

Columbia University Medical Center The Cardiovascular Research Foundation

Official's Role

Study Chair

Facility Information:

Facility Name

Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku

City

Białystok

Country

Poland

Facility Name

Gilghsin: John Paul II Hospital

City

Krakow

Country

Poland

Facility Name

Szpital Uniwersytecki w Krakowie

City

Krakow

Country

Poland

Facility Name

Oddział Kardiologii Inwazyjnej

City

Nowy Targ

Country

Poland

Facility Name

Centrum Kardiologii Inwazyjnej GVM Carint

City

Oświęcim

Country

Poland

Facility Name

Centralny Szpital Kliniczny MSWiA w Warszawie

City

Warsaw

Country

Poland

Facility Name

Milpark Hospital

City

Johannesburg

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

25603802

Citation

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.

Results Reference

derived

PubMed Identifier

25277335

Citation

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.

Results Reference

derived

PubMed Identifier

23103033

Citation

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.

Results Reference

derived

Learn more about this trial

Safety and Efficacy Study of MGuard Stent After a Heart Attack

We'll reach out to this number within 24 hrs