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

NCT01136187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2012-12-21

No results posted yet for this study

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

  • ST Elevation Myocardial Infarction

Interventions

PROCEDURE

Access site in primary PCI

Sponsors & Collaborators

  • University Hospital Pilsen

    collaborator OTHER

  • Regional Hospital Liberec

    collaborator OTHER

  • University Hospital Hradec Kralove

    collaborator OTHER

  • Na Homolce Hospital

    collaborator OTHER

  • Charles University, Czech Republic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-04-30
Completion
2012-10-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01136187 on ClinicalTrials.gov