Clinical Trials Directory

Trials / Completed

CompletedNCT01136187

Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)

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
Phase
N/A
Study type
Interventional
Enrollment
707 (actual)
Sponsor
Charles University, Czech Republic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAccess site in primary PCI

Timeline

Start date
2009-10-01
Primary completion
2012-04-01
Completion
2012-10-01
First posted
2010-06-03
Last updated
2012-12-21

Locations

4 sites across 1 country: Czechia

Source: ClinicalTrials.gov record NCT01136187. Inclusion in this directory is not an endorsement.