MedTrace Logo

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

NCT02061696 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-05-23

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DEVICE

Vascular Access Device

AXERA 2 Access System with Reduced Manual Compression

PROCEDURE

Standard Manual Compression

Closure procedure by Manual Compression

Sponsors & Collaborators

  • Borgess Medical Center

    collaborator UNKNOWN

  • Borgess Cardiology Group

    collaborator UNKNOWN

  • Borgess Heart Center for Excellence

    collaborator UNKNOWN

  • Frank Saltiel

    lead OTHER

Principal Investigators

  • Frank Saltiel, MD · Chairman, Borgess Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061696 on ClinicalTrials.gov