Clinical trial NCT01869738: MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction
Official title: MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: heart attack
Lead sponsor: InspireMD
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: rate of complete ST-segment resolution within 60-90 minutes
timeFrame: 60-90 minutes post-procedure
measure: 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.
timeFrame: 365 days post-procedure
Secondary outcomes:
measure: Infarct size assessed by cardiac magnetic resonance imaging (MRI)
timeFrame: 5 days post-procedure
measure: In-stent late lumen loss (LLL)
timeFrame: 13 months post-procedure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tampa
country: United States
facility: Pepin Heart Hospital
state: Florida
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Medical Group
state: Indiana
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Clinton
country: United States
facility: MedStar Southern Maryland Hospital Center
state: Maryland
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: Oxford
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Ridgewood
country: United States
facility: Valley Hospital
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Oberlin
country: United States
facility: Elyria Memorial Hospital
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology
state: Ohio
city: Camp Hill
country: United States
facility: Holy Spirit Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Clinic Cardiology
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Antwerp
country: Belgium
facility: ZNA Antwerpem
city: Hradec Kralove
country: Czech Republic
facility: University hospital
city: Prague
country: Czech Republic
facility: Na Homolce Hospital
city: Tallinn
country: Estonia
facility: North-Estonia Regional Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Lyon
country: France
facility: Hopital Louis Pradel
city: Massy
country: France
facility: Institut Jacques Cartier
city: Montfermeil
country: France
facility: Hôpitaux GHI Le Raincy - Montfermeil
city: Paris
country: France
facility: Hôptal Européen Georges Pompidou
city: Berlin
country: Germany
facility: Charité Universitätsklinikum Berlin Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Universitätsklinikum Berlin Campus Virchow
city: Munich
country: Germany
facility: Stadtische Kliniken München
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Ulm
country: Germany
facility: Universitat Ulm
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
state: AC
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Dordrecht
country: Netherlands
facility: Albert Schweitzerziekenhuis
city: Chrzanow
country: Poland
facility: Malopolskie Centrum Sercowo-Naczyniowe
city: Dąbrowa Górnicza
country: Poland
facility: Polsko-Amerykańskie Kliniki Serca
city: Katowice
country: Poland
facility: Górnośląskie Centrum Medyczne
city: Krakow
country: Poland
facility: Krakowskie Centrum Kardiologii Inwazyjnej
city: Krakow
country: Poland
facility: Szpital Uniwersyteckiw Krakowie
city: Krakow
country: Poland
facility: John Paul II Hospital
city: Warsaw
country: Poland
facility: Klinika Kardiologii i Angiologii Interwencyjnej
city: Łódź
country: Poland
facility: Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi
city: Barcelona
country: Spain
facility: Hospital Clinic, University of Barcelona
city: Barcelona
country: Spain
facility: Bellvitge University Hospital
city: Madrid
country: Spain
facility: Hospital Universitario Madrid Montepríncipe
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Southampton
country: United Kingdom
facility: University Hospitals Southampton NHS Foundation Trust
Study officials:
References: