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

ST Elevation Myocardial Infarction Clinical Trial

— MASTER-II  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01869738
• Other study ID #: IMD-10
• Status: Terminated
• Phase: N/A
• First received: May 28, 2013
• Last updated: August 31, 2015
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: InspireMD
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesBelgium: Ethics CommitteeFrance: Agence Nationale de Sécurité du Médicament et des produits de santéNetherlands: Medical Ethics Review Committee (METC)United Kingdom: National Institute for Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 310
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Device:
• MGuard Prime

• (BMS/DES)

Locations

Country	Name	City	State
Belgium	ZNA Antwerpem	Antwerp
Czech Republic	University hospital	Hradec Kralove
Czech Republic	Na Homolce Hospital	Prague
Estonia	North-Estonia Regional Hospital	Tallinn
Finland	Helsinki University Hospital	Helsinki
France	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
Germany	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
Israel	Rabin Medical Center	Petach Tikva
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam	AC
Netherlands	VU University Medical Center	Amsterdam
Netherlands	Albert Schweitzerziekenhuis	Dordrecht
Poland	Malopolskie Centrum Sercowo-Naczyniowe	Chrzanow
Poland	Polsko-Amerykanskie Kliniki Serca	Dabrowa Górnicza
Poland	Górnoslaskie Centrum Medyczne	Katowice
Poland	John Paul II Hospital	Krakow
Poland	Krakowskie Centrum Kardiologii Inwazyjnej	Krakow
Poland	Szpital Uniwersyteckiw Krakowie	Krakow
Poland	Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Klinika Kardiologii i Angiologii Interwencyjnej	Warsaw
Spain	Bellvitge University Hospital	Barcelona
Spain	Hospital Clinic, University of Barcelona	Barcelona
Spain	Hospital Universitario Madrid Montepríncipe	Madrid
United Kingdom	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 States	Asheville Cardiology Associates	Asheville	North Carolina
United States	MedStar Union Memorial Hospital	Baltimore	Maryland
United States	Holy Spirit Hospital	Camp Hill	Pennsylvania
United States	University of Virginia Health System	Charlottesville	Virginia
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	MedStar Southern Maryland Hospital Center	Clinton	Maryland
United States	Geisinger Clinic Cardiology	Danville	Pennsylvania
United States	Alexian Brothers Medical Center	Elk Grove Village	Illinois
United States	St. Vincent Medical Group	Indianapolis	Indiana
United States	Sparrow Clinical Research Institute	Lansing	Michigan
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	Elyria Memorial Hospital	Oberlin	Ohio
United States	Cardiology Associates of North Mississippi	Oxford	Mississippi
United States	Miriam Hospital	Providence	Rhode Island
United States	Valley Hospital	Ridgewood	New Jersey
United States	Beaumont Hospital	Royal Oak	Michigan
United States	Pepin Heart Hospital	Tampa	Florida
United States	Northwest Ohio Cardiology	Toledo	Ohio
United States	Winchester Medical Center	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
InspireMD

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  Estonia,  Finland,  France,  Germany,  Israel,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of complete ST-segment resolution within 60-90 minutes		60-90 minutes post-procedure	No
Primary	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	Yes
Secondary	Infarct size assessed by cardiac magnetic resonance imaging (MRI)		5 days post-procedure	No
Secondary	In-stent late lumen loss (LLL)		13 months post-procedure	No