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Myocardial InfarctionPhase 4MASTERNCT01368471

Safety and Efficacy Study of MGuard Stent After a Heart Attack

A Phase 4 study testing MGuard in people with Myocardial Infarction, run by InspireMD at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Myocardial Infarction
What is being tested?
MGuard
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
433 participants
Where
7 sitesin 2 countries
Study dates
Jun 2011to Jun 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 32Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Poland6 sites

  • Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku

    Bialystok

  • Gilghsin: John Paul II Hospital

    Krakow

  • Szpital Uniwersytecki w Krakowie

    Krakow

  • Oddział Kardiologii Inwazyjnej

    Nowy Targ

  • Centrum Kardiologii Inwazyjnej GVM Carint

    Oświęcim

  • Centralny Szpital Kliniczny MSWiA w Warszawie

    Warsaw

Other trials in Poland

South Africa1 site

  • Milpark Hospital

    Johannesburg

Other trials in South Africa

About this study

Official title: 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).

Being tested
MGuard, Control BMS or DES
Keywords
STEMI, myocardial infarction, stent
Medical subject headings
Myocardial Infarction, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Control BMS or DESDevice

    Control BMS or DES

Study groups in NCT01368471
Study groupRoleWhat they receive
MGuardExperimentalMGuard stent will be deployed
Receives: Device: MGuard
BMS or DESActive comparatorA regular bare metal stent or drug-eluting stent will be deployed
Receives: Device: Control BMS or DES

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 60 to 90 minutes after the last angiogram

Secondary outcomes (2)

  1. 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.

    Measured: 60-90 minutes after last angiogram

  2. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
433 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01368471
Sponsor's protocol ID
IMD-07
Acronym
MASTER
Status last verified
May 2013
First submitted
17 Feb 2011
Last updated
29 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25603802

  • 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.

    PubMed 25277335

  • 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.

    PubMed 23103033

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MGuard in people with Myocardial Infarction, run by InspireMD at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Poland, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01368471, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.

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