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

Terminated

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • 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

      • Antwerp, Belgium
        • ZNA Antwerpem
      • Hradec Kralove, Czech Republic
        • University Hospital
      • Prague, Czech Republic
        • Na Homolce Hospital
      • Tallinn, Estonia, 13419
        • North-Estonia Regional Hospital
      • Helsinki, Finland
        • Helsinki University Hospital
      • Créteil, France
        • Hôpital Henri Mondor
      • Lyon, France
        • Hopital Louis Pradel
      • Massy, France
        • Institut Jacques Cartier
      • Montfermeil, France
        • Hôpitaux GHI Le Raincy - Montfermeil
      • Paris, France
        • Hôptal Européen Georges Pompidou
      • 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
        • Universitat Ulm
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center
      • 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
      • Chrzanow, Poland
        • Malopolskie Centrum Sercowo-Naczyniowe
      • Dąbrowa Górnicza, Poland
        • Polsko-Amerykańskie Kliniki Serca
      • Katowice, Poland, 40-635
        • Gornoslaskie 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
      • Barcelona, Spain, 08907
        • Bellvitge University Hospital
      • Barcelona, Spain, 08036
        • Hospital Clinic, University of Barcelona
      • Madrid, Spain, 28660
        • Hospital Universitario Madrid Montepríncipe
      • 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
    • 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

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
Intervention / Treatment
Experimental: MGuard Prime
MGuard Prime stent
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.

What is the study measuring?

Primary Outcome Measures

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

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

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

June 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 2, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

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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