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Completed

NCT Number: NCT01136187

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

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.

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Hemorrhage Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Hradec Kralove, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Access site in primary PCI

Procedure

Primary outcomes

  1. Occurrence of bleeding or entry site complications

    Time frame: 30 days

Secondary outcomes

  1. Occurence of major adverse cardiovascular events

  2. Primary access site failure - conversion to another access

  3. Angiographical procedural success

  4. Contrast media consumption

  5. Procedural and fluoroscopic times

  6. Duration of hospital / ICU stay

  7. TVR/TLR + any new hospitalization

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Na Homolce Hospital
  • Regional Hospital Liberec
  • University Hospital Hradec Kralove
  • University Hospital Pilsen

Registry information

Official study 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.

Acronym: STEMI-RADIAL

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 3, 2010
Registry last updated
Dec 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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