ST-elevation Myocardial Infarction Clinical Trial
— GUARDIANOfficial title:
MGuard vs bAre-metal Stents Plus Manual Thrombectomy in Real World STEMI Patients: a Prospective Multicenter Randomized Trial
NCT number | NCT01124942 |
Other study ID # | NA116/09 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2010 |
Est. completion date | March 1, 2013 |
Verified date | March 2022 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 350 |
Est. completion date | March 1, 2013 |
Est. primary completion date | March 1, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >/= 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Federico II University of Naples | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
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. — View Citation
Rapacciuolo 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of MACE | Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure. | 1 month | |
Secondary | Complete ST-segment resolution | Complete (>70%) ST-segment resolution at 60 minutes post-revascularization | 60 minutes after revascularization | |
Secondary | Thrombolysis in myocardial infarction antegrade coronary flow | TIMI coronary flow at the end of the procedure | 30 minutes after revascularization | |
Secondary | Corrected TIMI Frame count | Corrected TIMI Frame count at the end of the procedure | 30 minutes after revascularization | |
Secondary | Infarct related area reduction and left ventricular ejection fraction recovery | Six-month infarct related area reduction and left ventricular ejection fraction recovery as compared with infarct related area and and left ventricular ejection fraction at admission. | 6 months | |
Secondary | Procedural device performance | Device performance evaluated during the procedure in terms of pushability, trackability, crossability and deliverability | 60 minutes after revascularizationl | |
Secondary | Number of MACE | Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure. | 6 months | |
Secondary | Number of MACE | Number of Major Adverse Cardiovascular Events experienced among study population, including: cardiac death, myocardial infarction, target vessel failure. | 12 months |
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