NCT02831166

Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Irmandade Santa Casa Misericórdia Marília · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.

Conditions

• Myocardial Infarction
• Complications; Device, Vascular
• Injury of Radial Artery
• Injury; Blood Vessel, Femoral, Artery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-10-01
• Completion: 2019-11-01
• First posted: 2016-07-13
• Last updated: 2020-02-11

Locations

1 site across 1 country: Brazil