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Prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of net adverse clinical outcomes (NACE) of transfemoral vs. transradial approach for the treatment of patients with ST-elevation acute coronary syndrome (STEACS) undergoing primary angioplasty
Prospective, randomized, double arm study. The study population will include all consecutive patients presenting with a ST-elevation Acute Coronary Syndrome and candidates for primary percutaneous coronary intervention, who agree and provide written informed consent for the study.
Before arterial stick for percutaneous access, patients will be randomized according to sealed numbered envelopes. Subsequently, arterial access will be obtained and the diagnostic/interventional procedure will be performed according to routine clinical practice, leaving ancillary medications, choice of devices and means of hemostasis at the physician's discretion.
In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial | Experimental | group of patients undergoing primary angioplasty by transradial approach |
|
| Femoral | Active Comparator | group of patients undergoing primary angioplasty by transfemoral approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral approach | Procedure | diagnostic and interventional procedures by femoral artery access |
|
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Event | Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding | 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Event | Cumulative of cardiac death, myocardial infarction, target lesion revascularization, stroke and bleeding | 1-year |
| Individual components of NACE | Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding |
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Inclusion Criteria:
Exclusion Criteria:
7.Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
8.Prior participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Ernesto Lioy, MD | Policlinico Casilino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università di Modena e Reggio Emilia | Modena | Modena | 41124 | Italy | ||
| Ospedale Sandro Pertini |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22858390 | Derived | Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2016 | |
| Reset | Aug 19, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2016 | Aug 19, 2016 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Radial approach | Procedure | diagnostic and interventional procedures by radial artery access |
|
|
| 30-day |
| Individual components of NACE | Cardiac death, Myocardial infarction, Target Lesion revascularization, Stroke, Major Bleeding | 1-year |
| Total procedural and fluoroscopy times for the index procedure | Comparison of procedural and fluoroscopy times between the two study groups | 1 day |
| Hospital stay | Days of hospitalization | 30-day |
| Rome |
| Rome |
| 00100 |
| Italy |
| Policlinico Casilino | Rome | Rome | 00100 | Italy |
| University of Turin, San Giovanni Battista Hospital | Turin | Turin | 10100 | Italy |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |