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

NCT01869738 | Terminated DMC

• 1 other identifier: IMD-10
• Study Type: interventional
• Target: 310
• Locations: 11 countries
• Sites: 55

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

Keywords

heart attack

Outcome Measures

Primary Outcomes (2)

• rate of complete ST-segment resolution within 60-90 minutes

  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.

  365 days post-procedure

Secondary Outcomes (2)

• Infarct size assessed by cardiac magnetic resonance imaging (MRI)

  5 days post-procedure

• In-stent late lumen loss (LLL)

  13 months post-procedure

Study Arms (2)

MGuard Prime

EXPERIMENTAL

MGuard Prime stent

Device: MGuard Prime

Control

ACTIVE 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.

Device: (BMS/DES)

Interventions

MGuard Prime DEVICE

MGuard Prime

(BMS/DES) DEVICE

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• InspireMD: lead

Study Sites (56)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Pepin Heart Hospital

Tampa, Florida, 33613, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

St. Vincent Medical Group

Indianapolis, Indiana, 46290, United States

Location

MedStar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

MedStar Southern Maryland Hospital Center

Clinton, Maryland, 20735, United States

Location

Sparrow Clinical Research Institute

Lansing, Michigan, 48910, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Cardiology Associates of North Mississippi

Oxford, Mississippi, 38655, United States

Location

Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

Columbia University Medical Center

New York, New York, 10027, United States

Location

Asheville Cardiology Associates

Asheville, North Carolina, 28803, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Elyria Memorial Hospital

Oberlin, Ohio, 44074, United States

Location

Northwest Ohio Cardiology

Toledo, Ohio, 43615, United States

Location

Holy Spirit Hospital

Camp Hill, Pennsylvania, 17011, United States

Location

Geisinger Clinic Cardiology

Danville, Pennsylvania, 17822, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

Location

Winchester Medical Center

Winchester, Virginia, 22604, United States

Location

ZNA Antwerpem

Antwerp, Belgium

Location

University hospital

Hradec Králové, Czechia

Location

Na Homolce Hospital

Prague, Czechia

Location

North-Estonia Regional Hospital

Tallinn, 13419, Estonia

Location

Helsinki University Hospital

Helsinki, Finland

Location

Hopital Henri Mondor

Créteil, France

Location

Hopital Louis Pradel

Lyon, France

Location

Institut Jacques Cartier

Massy, France

Location

Hôpitaux GHI Le Raincy - Montfermeil

Montfermeil, France

Location

Hôptal Européen Georges Pompidou

Paris, France

Location

Charité Universitätsklinikum Berlin Campus Benjamin Franklin

Berlin, 10117, Germany

Location

Charité Universitätsklinikum Berlin Campus Virchow

Berlin, 10117, Germany

Location

Stadtische Kliniken München

Munich, 81925, Germany

Location

Krankenhaus der Barmherzigen Brüder

Trier, 54292, Germany

Location

Universitat Ulm

Ulm, 89081, Germany

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, AC, 1091, Netherlands

Location

VU University Medical Center

Amsterdam, 1081, Netherlands

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Albert Schweitzerziekenhuis

Dordrecht, 3318, Netherlands

Location

Malopolskie Centrum Sercowo-Naczyniowe

Chrzanów, Poland

Location

Polsko-Amerykańskie Kliniki Serca

Dąbrowa Górnicza, Poland

Location

Górnośląskie Centrum Medyczne

Katowice, 40-635, Poland

Location

Krakowskie Centrum Kardiologii Inwazyjnej

Krakow, 30-693, Poland

Location

Szpital Uniwersyteckiw Krakowie

Krakow, 31-501, Poland

Location

John Paul II Hospital

Krakow, Poland

Location

Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi

Lodz, Poland

Location

Klinika Kardiologii i Angiologii Interwencyjnej

Warsaw, 04 - 628, Poland

Location

Hospital Clinic, University of Barcelona

Barcelona, 08036, Spain

Location

Bellvitge University Hospital

Barcelona, 08907, Spain

Location

Hospital Universitario Madrid Montepríncipe

Madrid, 28660, Spain

Location

Bristol Heart Institute

Bristol, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

University Hospitals Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 5, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

FR (5); IL (1); NL (4); CZ (2); BE (1); ES (3); US (20); GB (5); PL (8); DE (5); FI (1)