Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01136187
Status:
COMPLETED
Last Update Posted:
2012-12-21
First Post:
2010-06-02
Brief Title:
Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention PCI
Sponsor:
Charles University Czech Republic
Organization:
Charles University Czech Republic
Study Overview
Official Title:
ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI The STEMI-RADIAL Trial
Status:
COMPLETED
Status Verified Date:
2012-12
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:
STEMI-RADIAL
Brief Summary:
Percutaneous coronary interventions PCIs from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome ACS Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality Primary PCIs in ST elevation myocardial infarction STEMI are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions Currently both radial and femoral approaches are routinely used for primary PCI in STEMI However only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized multicenter study
Detailed Description:
None
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