NCT01653587

AngioSeal Versus Radial Approach in Acute Coronary Syndrome

Randomized Trial Between the Transfemoral Approach With AngioSeal and the Transradial Approach to Prevent Vascular Access Complications in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Submitted To Early Invasive Strategy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Irmandade Santa Casa Misericórdia Marília · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.

Detailed description

Antithrombotic therapy and percutaneous or surgical myocardial revascularization procedures are the basis of the treatment of patients admitted with non-ST-segment elevation acute coronary syndrome. However, the desired reduction of the recurrence of ischemic events has as complication an increased incidence of bleeding. Since arterial puncture followed by the insertion of an introducer has become the standard method to perform invasive cardiovascular procedures, complications related to vascular access have become an important bleeding site. Among the strategies to decrease vascular complications, the transradial approach is a well stablished alternative to the transfemoral approach. For its part, vascular closure devices were introduced to decrease vascular complications, homeostasis time and ambulation time of patients submitted to invasive procedures by the transfemoral access. Rapidly incorporated to the clinical practice, such devices to date have shown conflicting results with regard to their safety and efficacy. The inconsistency of data proving its safety limits its routine adoption as strategy to prevent vascular complications, requiring evidences through adequately designed randomized studies for this end.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention	Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines.

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-03-01
• Completion: 2016-03-01
• First posted: 2012-07-31
• Last updated: 2018-12-05
• Results posted: 2018-10-09

Locations

1 site across 1 country: Brazil