MGuard Stent in ST-elevation Myocardial Infarction
GUARDIAN
MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial
1 other identifier
interventional
350
1 country
1
Brief Summary
The Investigators will test the hypothesis that MGuard net protective stent, the investigational device, would be superior to conventional revascularization strategy (i.e. bare-metal stenting plus manual thrombectomy), for STEMI patients undergoing urgent percutaneous coronary interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
May 18, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedMarch 31, 2022
March 1, 2022
1 year
April 8, 2010
March 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with Myocardial Perfusional Blush Grade 2-3
Myocardial Perfusional Blush Grade 2-3 at the end of the procedure
30 minutes after revascularization
Secondary Outcomes (8)
Number of MACE
1 month
Complete ST-segment resolution
60 minutes after revascularization
Thrombolysis in myocardial infarction antegrade coronary flow
30 minutes after revascularization
Corrected TIMI Frame count
30 minutes after revascularization
Infarct related area reduction and left ventricular ejection fraction recovery
6 months
- +3 more secondary outcomes
Study Arms (2)
MGuard
EXPERIMENTALMGuard net protective stent, investigational device
BMS plus thrombectomy
ACTIVE COMPARATORBare-metal stent plus manual thrombectomy device
Interventions
It is a new closed-cell design stent concept. with an ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, anchored to the external surface of the struts. This net (string diameter 10-22 μm) minimally affects stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net.
Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent
Eligibility Criteria
You may qualify if:
- \>/= 18-year-old patients, willing to participate the study, after informed consent signature
- Female not pregnant or potentially child-bearing
- \> 1 mV ST segment elevation in two or more contiguous leads
- Acute MI lasting more than 30 minutes and less than 12 hours
- De novo acute MI
- Infarct related artery reference vessel diameter \>/= 2.5 mm
- Patient suitable for stenting according to vessel and lesion features
You may not qualify if:
- Dual antiplatelet therapy contraindication
- Ischemic stroke less than 30 days or previous haemorrhagic stroke
- WBC count less than 1000 per mm3;
- Platelet count less than 50.000 per mm3
- Life expectancy less than 1 year
- Cardiogenic shock at admission
- Previous stented infarct related artery
- Stent thrombosis as the responsible for current STEMI
- Inability to identify infarct related artery
- True bifurcation lesion, or lesion near a side branch with a reference vessel diameter \>/= 2.5 mm that could be diseased after stenting procedure
- LBBB
- Definitive pacing (or ECG abnormalities precluding ST-segment resolution evaluation
- Participation other study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federico II University of Naples
Naples, 80131, Italy
Related Publications (2)
Piscione F, Danzi GB, Cassese S, Esposito G, Cirillo P, Galasso G, Rapacciuolo A, Leosco D, Briguori C, Varbella F, Tuccillo B, Chiariello M. Multicentre experience with MGuard net protective stent in ST-elevation myocardial infarction: safety, feasibility, and impact on myocardial reperfusion. Catheter Cardiovasc Interv. 2010 Apr 1;75(5):715-21. doi: 10.1002/ccd.22292.
PMID: 19937780BACKGROUNDRapacciuolo A, D'andrea C, Maresca G, di Pietro E, Piscione F, Chiariello M. Multiple MGuard stent implantation to treat massive right coronary artery dissection during primary coronary angioplasty. J Cardiovasc Med (Hagerstown). 2011 May;12(5):356-60. doi: 10.2459/JCM.0b013e328334092d.
PMID: 20093945BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Federico Piscione, Associate Professor
Federico II University of Naples
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cardiologist
Study Record Dates
First Submitted
April 8, 2010
First Posted
May 18, 2010
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2013
Last Updated
March 31, 2022
Record last verified: 2022-03