MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction (MASTER-II)

August 31, 2015 updated by: InspireMD
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Belgium
      • Antwerp, Belgium
        • ZNA Antwerpem
  • Czech Republic
      • Hradec Kralove, Czech Republic
        • University Hospital
      • Prague, Czech Republic
        • Na Homolce Hospital
  • Estonia
      • Tallinn, Estonia, 13419
        • North-Estonia Regional Hospital
  • Finland
      • Helsinki, Finland
        • Helsinki university hospital
  • France
      • Créteil, France
        • Hôpital Henri Mondor
      • Lyon, France
        • Hôpital Louis Pradel
      • Massy, France
        • Institut Jacques Cartier
      • Montfermeil, France
        • Hôpitaux GHI Le Raincy - Montfermeil
      • Paris, France
        • Hôptal Européen Georges Pompidou
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsklinikum Berlin Campus Benjamin Franklin
      • Berlin, Germany, 10117
        • Charité Universitätsklinikum Berlin Campus Virchow
      • Munich, Germany, 81925
        • Stadtische Kliniken München
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder
      • Ulm, Germany, 89081
        • Universität Ulm
  • Israel
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center
      • Amsterdam, Netherlands, 1081
        • VU University Medical Center
      • Dordrecht, Netherlands, 3318
        • Albert SchweitzerZiekenhuis
    • AC
      • Amsterdam, AC, Netherlands, 1091
        • Onze Lieve Vrouwe Gasthuis
  • Poland
      • Chrzanow, Poland
        • Malopolskie Centrum Sercowo-Naczyniowe
      • Dąbrowa Górnicza, Poland
        • Polsko-Amerykanskie Kliniki Serca
      • Katowice, Poland, 40-635
        • Górnośląskie Centrum Medyczne
      • Krakow, Poland
        • John Paul II Hospital
      • Krakow, Poland, 30-693
        • Krakowskie Centrum Kardiologii Inwazyjnej
      • Krakow, Poland, 31-501
        • Szpital Uniwersyteckiw Krakowie
      • Warsaw, Poland, 04 - 628
        • Klinika Kardiologii i Angiologii Interwencyjnej
      • Łódź, Poland
        • Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi
  • Spain
      • Barcelona, Spain, 08907
        • Bellvitge University Hospital
      • Barcelona, Spain, 08036
        • Hospital Clinic, University of Barcelona
      • Madrid, Spain, 28660
        • Hospital Universitario Madrid Montepríncipe
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Heart Institute
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • Glasgow, United Kingdom
        • Golden Jubilee National Hospital
      • Leeds, United Kingdom
        • Leeds General Infirmary
      • Southampton, United Kingdom
        • University Hospitals Southampton NHS Foundation Trust
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Florida
      • Tampa, Florida, United States, 33613
        • Pepin Heart Hospital
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • St. Vincent Medical Group
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • MedStar Union Memorial Hospital
      • Clinton, Maryland, United States, 20735
        • MedStar Southern Maryland Hospital Center
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Sparrow Clinical Research Institute
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital
    • Mississippi
      • Oxford, Mississippi, United States, 38655
        • Cardiology Associates of North Mississippi
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • Valley Hospital
    • New York
      • New York, New York, United States, 10027
        • Columbia University Medical Center
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Cardiology Associates
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Oberlin, Ohio, United States, 44074
        • Elyria Memorial Hospital
      • Toledo, Ohio, United States, 43615
        • Northwest Ohio Cardiology
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Holy Spirit Hospital
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic Cardiology
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Health System
      • Winchester, Virginia, United States, 22604
        • Winchester Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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).
  • 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MGuard Prime
MGuard Prime stent
Device: MGuard Prime
Active Comparator: Control
(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.
Device: (BMS/DES)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
rate of complete ST-segment resolution within 60-90 minutes
Time Frame: 60-90 minutes post-procedure
60-90 minutes post-procedure
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.
Time Frame: 365 days post-procedure
365 days post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Infarct size assessed by cardiac magnetic resonance imaging (MRI)
Time Frame: 5 days post-procedure
5 days post-procedure
In-stent late lumen loss (LLL)
Time Frame: 13 months post-procedure
13 months post-procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InspireMD

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMD-10

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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