Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

PHASE4CompletedINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

October 31, 2019

Study Completion Date

November 30, 2019

Conditions
Myocardial InfarctionComplications; Device, VascularInjury of Radial ArteryInjury; Blood Vessel, Femoral, Artery
Interventions
PROCEDURE

Transradial primary percutaneous coronary intervention

Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow.

PROCEDURE

Transfemoral primary percutaneous coronary intervention

Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes.

Trial Locations (1)

17515900

Pedro Beraldo de Andrade, Marília

All Listed Sponsors
lead

Irmandade Santa Casa Misericórdia Marília

OTHER

NCT02831166 - Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention | Biotech Hunter | Biotech Hunter