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ST Elevation Myocardial InfarctionMASTER-IINCT01869738

MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction

A study testing MGuard Prime and (BMS/DES) in people with ST Elevation Myocardial Infarction, run by InspireMD at 56 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ST Elevation Myocardial Infarction
What is being tested?
MGuard Prime and (BMS/DES)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
56 sitesin 12 countries
Study dates
Jun 2013to Aug 2015
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is more than 18 years of age
  • Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of more than 30 minutes and less than 12 hours in duration.
  • ST elevation more than 2 mm per lead in more than 2 contiguous leads is present in one ECG prior to consent.
  • Subject agrees to all required follow-up procedures and visits.
  • Subject or legal representative provides written, informed consent.
  • The target lesion is a de novo lesion in a native coronary artery.
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  • Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.
  • The reference vessel diameter (RVD) of the infarct lesion is 2.75 to 4.0 mm by visual assessment, assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned).
  • The entire lesion length requiring treatment is less than 24 mm (able to be covered by a single study stent), assessed either at baseline (if direct stenting is planned), or after pre-dilatation or thrombus aspiration (if direct stenting is not planned)
  • TIMI flow of 2/3 is present prior to randomization (in case of baseline TIMI flow 0/1, blood flow must be restored).

Who cannot join

  • Left bundle branch block (LBBB), paced rhythm, or other ECG abnormality interfering with assessment of ST-segment.
  • Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  • A previous coronary interventional procedure of any kind within 30 days prior to the procedure.
  • Female patients of childbearing potential.
  • Subject undergoing cardiopulmonary resuscitation (patients in whom cardiopulmonary resuscitation was successfully performed and in whom normal mental status was achieved, may be enrolled).
  • Cardiogenic shock (SBP less than 80 mmHg for more than other hemodynamic support device for hypotension).
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  • The subject requires a staged procedure of the target vessel (including branches) within 12 months or of any non-target vessel within 7 days post-procedure.
  • The target lesion requires treatment with a device other than PTCA prior to stent placement (such as, but not limited to excimer laser, rotational atherectomy, etc.). Manual thrombus aspiration may be used per operator discretion, but rheolytic thrombectomy is only permitted for procedural complications after randomization.
  • Prior administration of thrombolytic therapy for the current admission
  • Co-morbid condition(s) that could limit the subject's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
  • Concurrent medical condition with a life expectancy of less than 12 months.
  • History of cerebrovascular accident or transient ischemic attack within the last 6 months, or any permanent neurologic deficit
  • Prior intracranial bleed at any time, or known intracranial pathology (e.g. tumor, arteriovenous malformation, or aneurysm).
  • Active or recent site of major bleeding within 6 months.
  • History of bleeding diathesis or coagulopathy or inability to accept blood transfusions.
  • Known hypersensitivity or contraindication to either i) aspirin, or heparin and bivalirudin; or ii) clopidogrel , ticlopidine, prasugrel and ticagrelor; or iii) cobalt or nickel; or iv) contrast media, which cannot be adequately pre-medicated (prior anaphylaxis, however, is an absolute contraindication to enrollment).
  • Known serum creatinine level more than 2.5 mg/dl, hemoglobin less than 10 g/dL or platelet count less than 150,000 for the present admission or within 7 days prior to index procedure, if available.
  • Surgery planned or any other reason necessitating discontinuation of dual anti-platelet therapy (aspirin and an ADP antagonist) within 12 months
  • Aortic dissection or mechanical complication of STEMI
  • Unprotected left main stenosis more than 50%.
  • Multi-vessel intervention required during the index procedure.
  • Excessive tortuosity, calcification or diffuse distal disease
  • A non-infarct lesion with stenosis more than 50% is present in the target vessel
  • Target lesion is a bifurcation with a side branch more than 2.0 mm in diameter.
  • Target lesion at the site of or within a vessel with a previously implanted stent
  • Target lesion is within a bypass graft conduit, or can only be reached by passing the study stent through a bypass graft conduit
  • In the Investigator's opinion the lesion/vessel is unsuitable for treatment with the study stent for any reason.
  • The lesion requires use of atherectomy, thrombectomy (not including manual thrombus aspiration catheters), laser devices, or proximal or distal embolic protection devices prior to randomization.
  • Aortic dissection or mechanical complication of STEMI

Trial locations and contacts

56 sites in 12 countries.

56 sites in 12 countries

United States20 sites

  • Asheville Cardiology Associates

    Asheville, North Carolina, 28803

  • MedStar Union Memorial Hospital

    Baltimore, Maryland, 21218

  • Holy Spirit Hospital

    Camp Hill, Pennsylvania, 17011

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • MedStar Southern Maryland Hospital Center

    Clinton, Maryland, 20735

  • Geisinger Clinic Cardiology

    Danville, Pennsylvania, 17822

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46290

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48910

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10027

  • Elyria Memorial Hospital

    Oberlin, Ohio, 44074

  • Cardiology Associates of North Mississippi

    Oxford, Mississippi, 38655

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Pepin Heart Hospital

    Tampa, Florida, 33613

  • Northwest Ohio Cardiology

    Toledo, Ohio, 43615

  • Winchester Medical Center

    Winchester, Virginia, 22604

Other trials in United States

Poland8 sites

  • Malopolskie Centrum Sercowo-Naczyniowe

    Chrzanów

  • Polsko-Amerykańskie Kliniki Serca

    Dąbrowa Górnicza

  • Górnośląskie Centrum Medyczne

    Katowice, 40-635

  • Krakowskie Centrum Kardiologii Inwazyjnej

    Krakow, 30-693

  • Szpital Uniwersyteckiw Krakowie

    Krakow, 31-501

  • John Paul II Hospital

    Krakow

  • Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi

    Lodz

  • Klinika Kardiologii i Angiologii Interwencyjnej

    Warsaw, 04 - 628

Other trials in Poland

France5 sites

  • Hopital Henri Mondor

    Créteil

  • Hopital Louis Pradel

    Lyon

  • Institut Jacques Cartier

    Massy

  • Hôpitaux GHI Le Raincy - Montfermeil

    Montfermeil

  • Hôptal Européen Georges Pompidou

    Paris

Other trials in France

Germany5 sites

  • Charité Universitätsklinikum Berlin Campus Benjamin Franklin

    Berlin, 10117

  • Charité Universitätsklinikum Berlin Campus Virchow

    Berlin, 10117

  • Stadtische Kliniken München

    Munich, 81925

  • Krankenhaus der Barmherzigen Brüder

    Trier, 54292

  • Universitat Ulm

    Ulm, 89081

Other trials in Germany

United Kingdom5 sites

  • Bristol Heart Institute

    Bristol

  • University Hospital of Wales

    Cardiff

  • Golden Jubilee National Hospital

    Glasgow

  • Leeds General Infirmary

    Leeds

  • University Hospitals Southampton NHS Foundation Trust

    Southampton

Other trials in United Kingdom

Netherlands4 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, AC, 1091

  • VU University Medical Center

    Amsterdam, 1081

  • Academic Medical Center

    Amsterdam

  • Albert Schweitzerziekenhuis

    Dordrecht, 3318

Other trials in Netherlands

Spain3 sites

  • Hospital Clinic, University of Barcelona

    Barcelona, 08036

  • Bellvitge University Hospital

    Barcelona, 08907

  • Hospital Universitario Madrid Montepríncipe

    Madrid, 28660

Other trials in Spain

Czechia2 sites

  • University hospital

    Hradec Králové

  • Na Homolce Hospital

    Prague

Other trials in Czechia

Belgium1 site

  • ZNA Antwerpem

    Antwerp

Other trials in Belgium

Estonia1 site

  • North-Estonia Regional Hospital

    Tallinn, 13419

Other trials in Estonia

Finland1 site

  • Helsinki University Hospital

    Helsinki

Other trials in Finland

Israel1 site

  • Rabin Medical Center

    Petah Tikva, 49100

Other trials in Israel

About this study

To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.

Being tested
MGuard Prime, (BMS/DES)
Keywords
heart attack
Medical subject headings
ST Elevation Myocardial Infarction, Myocardial Infarction

What participants receive

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

  • MGuard PrimeDevice

  • (BMS/DES)Device

Study groups in NCT01869738
Study groupRoleWhat they receive
MGuard PrimeExperimentalMGuard Prime stent
Receives: Device: MGuard Prime
ControlActive comparator(BMS/DES) Includes FDA approved bare metal or drug eluting stents, including ENDEAVOR, TAXUS Liberte, XIENCE Prime, PROMUS Element, ION, RESOLUTE, Driver, Vision, VeriFlex and Integrity.
Receives: Device: (BMS/DES)

What is being measured

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

  1. rate of complete ST-segment resolution within 60-90 minutes

    Measured: 60-90 minutes post-procedure

  2. The primary safety endpoint is a composite of all-cause death or recurrent target vessel myocardial infarction (TV re-MI) at 365 days post-procedure, powered to demonstrate non-inferiority of the MGuard™ Prime Stent compared to the control arm.

    Measured: 365 days post-procedure

Secondary outcomes (2)

  1. Infarct size assessed by cardiac magnetic resonance imaging (MRI)

    Measured: 5 days post-procedure

  2. In-stent late lumen loss (LLL)

    Measured: 13 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 posted5 Jun 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionAug 2015
  4. Study completionAug 2015

Why it stopped: low enrollment rate

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
310 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01869738
Sponsor's protocol ID
IMD-10
Acronym
MASTER-II
Status last verified
Aug 2015
First submitted
28 May 2013
Last updated
2 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing MGuard Prime and (BMS/DES) in people with ST Elevation Myocardial Infarction, run by InspireMD at 56 sites in 12 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 10 inclusion and 29 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: stopped early, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Poland, France, Germany, United Kingdom and 7 more countries. 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.

Are results available for this study?

The study was stopped early (reason given: low enrollment rate). Results are not available in the source record.

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?

rate of complete ST-segment resolution within 60-90 minutes (time frame: 60-90 minutes post-procedure). The study lists 2 primary outcomes in all. 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 NCT01869738.

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 2 Sep 2015.

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