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

Not Applicable

Completed

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Procedure: Access site in primary PCI

• Registration Number: NCT01136187
• Lead Sponsor: Charles University, Czech Republic

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

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2012-04
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-20
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 707

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral approach	Access site in primary PCI	Primary percutaneous coronary intervention from the femoral approach
Radial approach	Access site in primary PCI	Primary percutaneous coronary intervention from the radial approach

Primary Outcome Measures

Name	Time	Method
Occurrence of bleeding or entry site complications	30 days

Secondary Outcome Measures

Name	Time	Method
TVR/TLR + any new hospitalization
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

Trial Locations

Locations (4)

University Hospital Pilsen; 🇨🇿 Pilsen, Czech Republic

Na Homolce Hospital; 🇨🇿 Prague, Czech Republic

University Hospital Hradec Kralove; 🇨🇿 Hradec Kralove, Czech Republic

Regional Hospital Liberec; 🇨🇿 Liberec, Czech Republic