Safety and Efficacy Study of MGuard Stent After a Heart Attack

NCT ID: NCT01368471

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

Brief Summary

The goal of this study is to demonstrate the superiority of the MGuard™ stent over commercially-approved bare-metal (BMS) /drug-eluting stents (DES) in achieving better myocardial reperfusion in primary angioplasty for the treatment of acute ST-elevation myocardial infarction (STEMI).

Conditions

Myocardial Infarction

Study Design

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

Study Groups

MGuard

MGuard stent will be deployed

Group Type: EXPERIMENTAL

MGuard

Intervention Type: DEVICE

MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.

BMS or DES

A regular bare metal stent or drug-eluting stent will be deployed

Group Type: ACTIVE_COMPARATOR

Control BMS or DES

Intervention Type: DEVICE

Control BMS or DES

Interventions

MGuard

MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.

Intervention Type: DEVICE

Control BMS or DES

Control BMS or DES

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years of age
• ST-segment elevation (more than 2mm in more than contiguous leads)
• MI with symptom onset less than 12h
• The patient is willing to comply with specified follow-up evaluations
• Signed ICF
• Single de novo lesion in the target (culprit) vessel
• Target lesion maximum length is 33 mm (by visual estimation)
• Reference vessel diameter must be more than 3.0 to less than 4.0 mm by visual estimation

Exclusion Criteria

• Pregnant or nursing patients
• Left Bundle Branch Block (LBBB), paced rhythm, or other Electrocardiogram (ECG) abnormality
• Impaired renal function
• Prior coronary artery bypass graft surgery
• Bleeding diathesis
• Contraindication to aspirin
• cardiopulmonary resuscitation
• Cardiogenic shock
• chronic warfarin anticoagulation
• LVEF less than 20%
• other medical illness
• participation in another investigational drug or device study that has not reached its primary endpoint
• Left main coronary artery disease with 50% stenosis
• Ostial target lesion
• Failure to visualize vessel anatomy distal to the culprit lesion
• Moderate to heavily calcified target lesion or vessel
• excessive tortuosity
• bifurcation with a side branch more than 2.0 mm in diameter
• A significant (greater than 50%) stenosis proximal or distal to the target lesion is present that cannot be covered by same single stent
• Diffuse disease distal to target lesion with impaired runoff
• Any prior stent proximal to the target lesion, or within 10 mm distal of the target lesion
• PCI of another lesion performed within 6 months before the index procedure
• Target lesion located in a saphenous vein graft

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InspireMD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Abizaid, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inst Dante Pazzanese of Cardiology, Brazil

Dariusz Dudek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cardiac Catheterization Laboratories, Krakow, Poland

Sigmund Silber, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Center at the Isar Academic Teaching Site of the University of Munich

Gregg Stone, MD

Role: STUDY_CHAIR

Columbia University Medical Center The Cardiovascular Research Foundation

Locations

Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Białymstoku

Bialystok, , Poland

Gilghsin: John Paul II Hospital

Krakow, , Poland

Szpital Uniwersytecki w Krakowie

Krakow, , Poland

Oddział Kardiologii Inwazyjnej

Nowy Targ, , Poland

Centrum Kardiologii Inwazyjnej GVM Carint

Oświęcim, , Poland

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Milpark Hospital

Johannesburg, , South Africa

Countries

Poland; South Africa

References

Dudek D, Dziewierz A, Brener SJ, Abizaid A, Merkely B, Costa RA, Bar E, Rakowski T, Kornowski R, Dressler O, Abizaid A, Silber S, Stone GW. Mesh-covered embolic protection stent implantation in ST-segment-elevation myocardial infarction: final 1-year clinical and angiographic results from the MGUARD for acute ST elevation reperfusion trial. Circ Cardiovasc Interv. 2015 Feb;8(2):e001484. doi: 10.1161/CIRCINTERVENTIONS.114.001484.

Reference Type: DERIVED

PMID: 25603802 (View on PubMed)

Dudek D, Brener SJ, Rakowski T, Dziewierz A, Abizaid A, Silber S, Yaacoby E, Dizon JM, Costa RA, Maehara A, Dressler O, Stone GW. Efficacy of an Embolic Protection Stent as a Function of Delay to Reperfusion in ST-Segment Elevation Myocardial Infarction (from the MASTER Trial). Am J Cardiol. 2014 Nov 15;114(10):1485-9. doi: 10.1016/j.amjcard.2014.08.007. Epub 2014 Aug 27.

Reference Type: DERIVED

PMID: 25277335 (View on PubMed)

Stone GW, Abizaid A, Silber S, Dizon JM, Merkely B, Costa RA, Kornowski R, Abizaid A, Wojdyla R, Maehara A, Dressler O, Brener SJ, Bar E, Dudek D. Prospective, Randomized, Multicenter Evaluation of a Polyethylene Terephthalate Micronet Mesh-Covered Stent (MGuard) in ST-Segment Elevation Myocardial Infarction: The MASTER Trial. J Am Coll Cardiol. 2012 Nov 6;60(19):1975-84. doi: 10.1016/j.jacc.2012.09.004.

Reference Type: DERIVED

PMID: 23103033 (View on PubMed)

Other Identifiers

IMD-07

Identifier Type: -

Identifier Source: org_study_id