Ignite Creation Date:
2024-05-05 @ 11:48 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01420614
Status:
UNKNOWN
Last Update Posted:
2012-02-07
First Post:
2011-08-15
Brief Title:
RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome
Sponsor:
Policlinico Casilino ASL RMB
Organization:
Policlinico Casilino ASL RMB
Study Overview
Official Title:
RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RIFLE-STEACS
Brief Summary:
Prospective randomized multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes NACE of transfemoral vs transradial approach for the treatment of patients with ST-elevation acute coronary syndrome STEACS undergoing primary angioplasty
Detailed Description:
Prospective randomized double arm study The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention who agree and provide written informed consent for the study
Before arterial stick for percutaneous access patients will be randomized according to sealed numbered envelopes Subsequently arterial access will be obtained and the diagnosticinterventional procedure will be performed according to routine clinical practice leaving ancillary medications choice of devices and means of hemostasis at the physicians discretion
In the randomization process all participating centers will be equally stratified to avoid statistical unbalance
Before arterial stick for percutaneous access patients will be randomized according to sealed numbered envelopes Subsequently arterial access will be obtained and the diagnosticinterventional procedure will be performed according to routine clinical practice leaving ancillary medications choice of devices and means of hemostasis at the physicians discretion
In the randomization process all participating centers will be equally stratified to avoid statistical unbalance
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