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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01136187

Acronym

STEMI-RADIAL

Enrollment

707

Registered

2010-06-03

Start date

2009-10-31

Completion date

2012-10-31

Last updated

2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST Elevation Myocardial Infarction

Keywords

Myocardial infarction, Primary percutaneous coronary intervention, Radial, Bleeding

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.

Interventions

PROCEDUREAccess site in primary PCI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurrence of bleeding or entry site complications	30 days

Secondary

Measure	Time frame
Primary access site failure - conversion to another access	—
Angiographical procedural success	—
Contrast media consumption	—
Occurence of major adverse cardiovascular events	—
Duration of hospital / ICU stay	—
TVR/TLR + any new hospitalization	—
Procedural and fluoroscopic times	—

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026