Clinical Trials Directory

Trials / Unknown

UnknownNCT01420614

RadIal Versus Femoral InvEstigation in ST Elevation Acute Coronary Syndrome

RadIal Versus Femoral Randomized InvEstigation in ST Elevation Acute Coronary Syndrome

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
1,001 (actual)
Sponsor
Policlinico Casilino ASL RMB · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.

Conditions

Interventions

TypeNameDescription
PROCEDUREFemoral approachdiagnostic and interventional procedures by femoral artery access
PROCEDURERadial approachdiagnostic and interventional procedures by radial artery access

Timeline

Start date
2009-01-01
Primary completion
2011-07-01
Completion
2012-07-01
First posted
2011-08-19
Last updated
2012-02-07

Locations

4 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT01420614. Inclusion in this directory is not an endorsement.