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

NCT ID: NCT01869738

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-08-31

Brief 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. 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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MGuard Prime

MGuard Prime stent

Group Type: EXPERIMENTAL

MGuard Prime

Intervention Type: DEVICE

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.

Group Type: ACTIVE_COMPARATOR

(BMS/DES)

Intervention Type: DEVICE

Interventions

MGuard Prime

Intervention Type: DEVICE

(BMS/DES)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InspireMD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Pepin Heart Hospital

Tampa, Florida, United States

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

St. Vincent Medical Group

Indianapolis, Indiana, United States

MedStar Union Memorial Hospital

Baltimore, Maryland, United States

MedStar Southern Maryland Hospital Center

Clinton, Maryland, United States

Sparrow Clinical Research Institute

Lansing, Michigan, United States

Beaumont Hospital

Royal Oak, Michigan, United States

Cardiology Associates of North Mississippi

Oxford, Mississippi, United States

Valley Hospital

Ridgewood, New Jersey, United States

Columbia University Medical Center

New York, New York, United States

Asheville Cardiology Associates

Asheville, North Carolina, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Elyria Memorial Hospital

Oberlin, Ohio, United States

Northwest Ohio Cardiology

Toledo, Ohio, United States

Holy Spirit Hospital

Camp Hill, Pennsylvania, United States

Geisinger Clinic Cardiology

Danville, Pennsylvania, United States

Miriam Hospital

Providence, Rhode Island, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Winchester Medical Center

Winchester, Virginia, United States

ZNA Antwerpem

Antwerp, , Belgium

University hospital

Hradec Králové, , Czechia

Na Homolce Hospital

Prague, , Czechia

North-Estonia Regional Hospital

Tallinn, , Estonia

Helsinki University Hospital

Helsinki, , Finland

Hopital Henri Mondor

Créteil, , France

Hopital Louis Pradel

Lyon, , France

Institut Jacques Cartier

Massy, , France

Hôpitaux GHI Le Raincy - Montfermeil

Montfermeil, , France

Hôptal Européen Georges Pompidou

Paris, , France

Charité Universitätsklinikum Berlin Campus Benjamin Franklin

Berlin, , Germany

Charité Universitätsklinikum Berlin Campus Virchow

Berlin, , Germany

Stadtische Kliniken München

Munich, , Germany

Krankenhaus der Barmherzigen Brüder

Trier, , Germany

Universitat Ulm

Ulm, , Germany

Rabin Medical Center

Petah Tikva, , Israel

Onze Lieve Vrouwe Gasthuis

Amsterdam, AC, Netherlands

VU University Medical Center

Amsterdam, , Netherlands

Academic Medical Center

Amsterdam, , Netherlands

Albert Schweitzerziekenhuis

Dordrecht, , Netherlands

Malopolskie Centrum Sercowo-Naczyniowe

Chrzanów, , Poland

Polsko-Amerykańskie Kliniki Serca

Dąbrowa Górnicza, , Poland

Górnośląskie Centrum Medyczne

Katowice, , Poland

Krakowskie Centrum Kardiologii Inwazyjnej

Krakow, , Poland

Szpital Uniwersyteckiw Krakowie

Krakow, , Poland

John Paul II Hospital

Krakow, , Poland

Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi

Lodz, , Poland

Klinika Kardiologii i Angiologii Interwencyjnej

Warsaw, , Poland

Hospital Clinic, University of Barcelona

Barcelona, , Spain

Bellvitge University Hospital

Barcelona, , Spain

Hospital Universitario Madrid Montepríncipe

Madrid, , Spain

Bristol Heart Institute

Bristol, , United Kingdom

University Hospital of Wales

Cardiff, , United Kingdom

Golden Jubilee National Hospital

Glasgow, , United Kingdom

Leeds General Infirmary

Leeds, , United Kingdom

University Hospitals Southampton NHS Foundation Trust

Southampton, , United Kingdom

Countries

United States; Belgium; Czechia; Estonia; Finland; France; Germany; Israel; Netherlands; Poland; Spain; United Kingdom

Other Identifiers

IMD-10

Identifier Type: -

Identifier Source: org_study_id