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ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System — ARISTOCRAT  

Coronary Artery Disease Clinical Trial

Official title:
A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression

Clinical Trial Summary

The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression.

Clinical Trial Description

The study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and PCI.

It is anticipated that the enrollment period for this study will be two years.

The post procedure follow up period is up to 37 days following the procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02061696
Study type Interventional
Source Borgess Research Institute
Contact
Status Terminated
Phase N/A
Start date January 2014
Completion date January 2016
View Details
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