Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03087175
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2016-11-14
Brief Title:
MGuard Stent and Microcirculation
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Impact of Polyethylene Terephthalate Micronet Mesh-Covered Stent MGuard on Coronary Microcirculations Lesions in Patients With ST or Non ST-segment Elevation Myocardial Infarction STE and NSTE-ACS Assessment by Index of Microcirculatory Resistance IMR
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUARDIANCORY
Brief Summary:
NSTE-ACS represents the most frequent indication for coronary angiography and percutaneous coronary intervention PCI worldwide PCI permit to reestablished coronary flow but effectiveness of PCI within thrombus containing lesions is limited by the risk of occurrence of distal embolization and no-reflow phenomenon Distal embolization lead to coronary microcirculation lesions This complication is related to poor prognosis
MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction
Index of microcirculatory resistance IMR is a validated method to assess coronary microcirculation
Accordingly the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI compared with a bare metal stent BMS and drug eluting stent DES in patients with NSTE-ACS assessed by Index of microcirculatory resistance
MGuard stent is a stainless-steel closed cell stent covered with an ultra-thin polymer mesh sleeve which allows to prevent distal embolization during percutaneous coronary intervention in ST-segment-elevation myocardial infarction
Index of microcirculatory resistance IMR is a validated method to assess coronary microcirculation
Accordingly the purpose of this study is to demonstrate that MGuard micronet mesh-covered stent prevent distal embolization and microvascular reperfusion impairment during primary PCI compared with a bare metal stent BMS and drug eluting stent DES in patients with NSTE-ACS assessed by Index of microcirculatory resistance
Detailed Description:
GUARDIANCORY study is a multicentre prospective randomized non inferiority open-label trial with a planned inclusion of 52 patients with STE and NSTE ACS and prescribed PCI Patients will be randomized to benefiting either DES BMS implantation n26 or MGuard stent n26 on the culprit lesion Assessment of coronary microcirculation will be done by IMR immediately after PCI by using a pressure-temperature sensor-tipped coronary wire thermodilution-derived
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None