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

This study has been completed.
Sponsor:
Collaborators:
University Hospital Pilsen
Regional Hospital Liberec
University Hospital Hradec Kralove
Na Homolce Hospital
Information provided by (Responsible Party):
Ivo Bernat, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01136187
First received: June 2, 2010
Last updated: December 20, 2012
Last verified: December 2012

June 2, 2010
December 20, 2012
October 2009
April 2012   (final data collection date for primary outcome measure)
Occurrence of bleeding or entry site complications [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT01136187 on ClinicalTrials.gov Archive Site
  • Occurence of major adverse cardiovascular events
  • Primary access site failure - conversion to another access
  • Angiographical procedural success
  • Contrast media consumption
  • Procedural and fluoroscopic times
  • Duration of hospital / ICU stay
  • TVR/TLR + any new hospitalization
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
ST Elevation Myocardial Infarction
Procedure: Access site in primary PCI
  • Experimental: Radial approach
    Primary percutaneous coronary intervention from the radial approach
    Intervention: Procedure: Access site in primary PCI
  • Active Comparator: Femoral approach
    Primary percutaneous coronary intervention from the femoral approach
    Intervention: Procedure: Access site in primary PCI
Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
707
October 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age over 18 years
  • Admission for STEMI less than 12 hours after onset of symptoms

    1. Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
    2. Patients are planned to be treated with primary PCI
  • Ability to sign written informed consent

Exclusion Criteria:

  • Killip IV class or unconsciousness
  • Patient disagreement
  • Prior aortobifemoral bypass
  • Absence of both radial or femoral artery pulsation
  • Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
  • Negative Allen's test or Barbeau test type D
  • Treatment with oral anticoagulants
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT01136187
STEMI-RADIAL 16-9-2009
Not Provided
Ivo Bernat, Charles University, Czech Republic
Charles University, Czech Republic
  • University Hospital Pilsen
  • Regional Hospital Liberec
  • University Hospital Hradec Kralove
  • Na Homolce Hospital
Not Provided
Charles University, Czech Republic
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP