Safety and Efficacy Study of MGuard Stent After a Heart Attack

Myocardial Infarction Clinical Trial

— MASTER  

Official title:

MASTER: MGUARD for Acute ST Elevation Reperfusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368471
• Other study ID #: IMD-07
• Status: Completed
• Phase: Phase 4
• First received: February 17, 2011
• Last updated: May 28, 2013
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: InspireMD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Randomization should occur as soon as Presence of TIMI 2 or 3 before randomization 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

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

Intervention

Device:
• 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.
• Control BMS or DES
Control BMS or DES

Locations

Country	Name	City	State
Poland	Klinika Kardiologii Inwazyjnej Uniwersytetu Medycznego w Bialymstoku	Bialystok
Poland	Gilghsin: John Paul II Hospital	Krakow
Poland	Szpital Uniwersytecki w Krakowie	Krakow
Poland	Oddzial Kardiologii Inwazyjnej	Nowy Targ
Poland	Centrum Kardiologii Inwazyjnej GVM Carint	Oswiecim
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw
South Africa	Milpark Hospital	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
InspireMD

Countries where clinical trial is conducted

Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of complete ST segment resolution (defined as =70% ST 1. The incidence of complete ST segment resolution		60 to 90 minutes after the last angiogram	No
Secondary	The incidence of Thrombolysis In Myocardial Infarction (TIMI) 3 flow at the end of the procedure.	The incidence of TIMI 3 flow at the end of the procedure.	60-90 minutes after last angiogram	No
Secondary	Major Adverse Cardiac Events (MACE)at discharge, 30 days, 6 months and 12 months post-procedure	Major Adverse Cardiac Events (MACE): defined as cardiac death, reinfarction (Q wave and non-Q wave), or repeat ischemia-driven target lesion revascularization (TLR) by percutaneous or surgical methods at hospital discharge, 30 days, 6 months and 1 year post-procedure.	discharge, 30 days, 6 and 12 months post-procedure	Yes