Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI) (STEMI-RADIAL)
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ClinicalTrials.gov Identifier: NCT01136187 |
Recruitment Status
:
Completed
First Posted
: June 3, 2010
Last Update Posted
: December 21, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
ST Elevation Myocardial Infarction | Procedure: Access site in primary PCI | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 707 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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. |
Study Start Date : | October 2009 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Radial approach
Primary percutaneous coronary intervention from the radial approach
|
Procedure: Access site in primary PCI |
Active Comparator: Femoral approach
Primary percutaneous coronary intervention from the femoral approach
|
Procedure: Access site in primary PCI |
- Occurrence of bleeding or entry site complications [ Time Frame: 30 days ]
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01136187
Czech Republic | |
University Hospital Hradec Kralove | |
Hradec Kralove, Czech Republic, 50005 | |
Regional Hospital Liberec | |
Liberec, Czech Republic, 46063 | |
University Hospital Pilsen | |
Pilsen, Czech Republic, 30460 | |
Na Homolce Hospital | |
Prague, Czech Republic, 15030 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ivo Bernat, MD, PhD, Charles University, Czech Republic |
ClinicalTrials.gov Identifier: | NCT01136187 History of Changes |
Other Study ID Numbers: |
STEMI-RADIAL 16-9-2009 |
First Posted: | June 3, 2010 Key Record Dates |
Last Update Posted: | December 21, 2012 |
Last Verified: | December 2012 |
Keywords provided by Ivo Bernat, Charles University, Czech Republic:
Myocardial infarction Primary percutaneous coronary intervention Radial Bleeding |
Additional relevant MeSH terms:
Infarction Myocardial Infarction ST Elevation Myocardial Infarction Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |