- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869738
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
Conditions
Intervention / Treatment
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
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Antwerp, Belgium
- ZNA Antwerpem
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Hradec Kralove, Czech Republic
- University Hospital
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Prague, Czech Republic
- Na Homolce Hospital
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Tallinn, Estonia, 13419
- North-Estonia Regional Hospital
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Helsinki, Finland
- Helsinki University Hospital
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Créteil, France
- Hôpital Henri Mondor
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Lyon, France
- Hopital Louis Pradel
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Massy, France
- Institut Jacques Cartier
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Montfermeil, France
- Hôpitaux GHI Le Raincy - Montfermeil
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Paris, France
- Hôptal Européen Georges Pompidou
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Berlin, Germany, 10117
- Charité Universitätsklinikum Berlin Campus Benjamin Franklin
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Berlin, Germany, 10117
- Charité Universitätsklinikum Berlin Campus Virchow
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Munich, Germany, 81925
- Stadtische Kliniken München
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Trier, Germany, 54292
- Krankenhaus der Barmherzigen Brüder
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Ulm, Germany, 89081
- Universitat Ulm
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Petach Tikva, Israel, 49100
- Rabin Medical Center
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Amsterdam, Netherlands
- Academic Medical Center
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Amsterdam, Netherlands, 1081
- VU University Medical Center
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Dordrecht, Netherlands, 3318
- Albert SchweitzerZiekenhuis
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AC
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Amsterdam, AC, Netherlands, 1091
- Onze Lieve Vrouwe Gasthuis
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Chrzanow, Poland
- Malopolskie Centrum Sercowo-Naczyniowe
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Dąbrowa Górnicza, Poland
- Polsko-Amerykańskie Kliniki Serca
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Katowice, Poland, 40-635
- Gornoslaskie Centrum Medyczne
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Krakow, Poland
- John Paul II Hospital
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Krakow, Poland, 30-693
- Krakowskie Centrum Kardiologii Inwazyjnej
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Krakow, Poland, 31-501
- Szpital Uniwersyteckiw Krakowie
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Warsaw, Poland, 04 - 628
- Klinika Kardiologii i Angiologii Interwencyjnej
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Łódź, Poland
- Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi
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Barcelona, Spain, 08907
- Bellvitge University Hospital
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Barcelona, Spain, 08036
- Hospital Clinic, University of Barcelona
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Madrid, Spain, 28660
- Hospital Universitario Madrid Montepríncipe
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Bristol, United Kingdom
- Bristol Heart Institute
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Cardiff, United Kingdom
- University Hospital of Wales
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Glasgow, United Kingdom
- Golden Jubilee National Hospital
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Leeds, United Kingdom
- Leeds General Infirmary
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Southampton, United Kingdom
- University Hospitals Southampton NHS Foundation Trust
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale University School of Medicine
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Florida
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Tampa, Florida, United States, 33613
- Pepin Heart Hospital
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Medical Center
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Indiana
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Indianapolis, Indiana, United States, 46290
- St. Vincent Medical Group
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Maryland
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Baltimore, Maryland, United States, 21218
- MedStar Union Memorial Hospital
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Clinton, Maryland, United States, 20735
- MedStar Southern Maryland Hospital Center
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Michigan
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Lansing, Michigan, United States, 48910
- Sparrow Clinical Research Institute
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Royal Oak, Michigan, United States, 48073
- Beaumont Hospital
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Mississippi
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Oxford, Mississippi, United States, 38655
- Cardiology Associates of North Mississippi
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New Jersey
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Ridgewood, New Jersey, United States, 07450
- Valley Hospital
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New York
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New York, New York, United States, 10027
- Columbia University Medical Center
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North Carolina
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Asheville, North Carolina, United States, 28803
- Asheville Cardiology Associates
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
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Oberlin, Ohio, United States, 44074
- Elyria Memorial Hospital
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Toledo, Ohio, United States, 43615
- Northwest Ohio Cardiology
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Pennsylvania
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Camp Hill, Pennsylvania, United States, 17011
- Holy Spirit Hospital
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Danville, Pennsylvania, United States, 17822
- Geisinger Clinic Cardiology
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Miriam Hospital
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia Health System
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Winchester, Virginia, United States, 22604
- Winchester Medical Center
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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 |
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Experimental: MGuard Prime
MGuard Prime stent
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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rate of complete ST-segment resolution within 60-90 minutes
Time Frame: 60-90 minutes post-procedure
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60-90 minutes post-procedure
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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
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365 days post-procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Infarct size assessed by cardiac magnetic resonance imaging (MRI)
Time Frame: 5 days post-procedure
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5 days post-procedure
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In-stent late lumen loss (LLL)
Time Frame: 13 months post-procedure
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13 months post-procedure
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
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Clinical Trials on MGuard Prime
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InspireMDTerminatedST Elevation Myocardial InfarctionNetherlands
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InspireMDWithdrawnST Segment Elevated Myocardial InfarctionUnited Kingdom
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InspireMDCompletedAcute Coronary Syndrome | Ischemic Heart Disease | Acute Myocardial InfarctionIsrael
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InspireMDCompletedMyocardial InfarctionPoland, South Africa
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Federico II UniversityCompletedST-elevation Myocardial Infarction | Thrombus | StentsItaly
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University Hospital, GrenobleCompletedCardiovascular Diseases | Coronary Artery Disease | Coronary Disease | Coronary AtherosclerosisFrance
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Yale-NUS CollegeCompleted
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Ajou University School of MedicineCompletedIntravenous Drug UsageKorea, Republic of
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University of California, San FranciscoWithdrawnDepressionUnited States
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University of UtahCompletedBasic Motor Learning ProblemUnited States