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

April 23, 2018 updated by: Frank Saltiel

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is between 18 and 85 years of age.
  • Cardiac catheterization procedure is indicated with involving access through a 5 French (F) or 6 French (F) introducer in the femoral artery.
  • Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
  • Subject or legally authorized representative has signed informed consent.

Exclusion Criteria:

  • Subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis)
  • Subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure).
  • Subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction.
  • Extensive calcification of the femoral artery as see on fluoroscopy.
  • Subject has systemic hypertension unresponsive to treatment (>180mm Hg systolic and >110mm Hg diastolic).
  • Subject has received thrombolytic therapy within the 72 hours prior to catheterization.
  • Subject has known bleeding disorder,such as Factor 5 deficiency, Idiopathic thrombocytopenic purpura (ITP), thrombasthenia, Von Willebrand's disease.
  • Is on warfarin with an International Ratio (INR)>1.5.
  • Platelet count is < 100,000.
  • Anemia (Hemoglobin <10 g/dl or Hematocrit<30%).
  • Subject has compromised femoral artery access site.
  • Subject procedure requires an introducer sheath size of > 6 French (F).
  • Subject has had prior vascular surgery or vascular grafts at the femoral artery access site.
  • Subject presents with hemodynamic instability or is in need of emergent surgery.
  • Subject has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days.
  • Subject has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of < 1 year.
  • Subject is participating in an investigational drug or another device research study that interferes with the current research study endpoints.
  • Pregnant or lactating subjects.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard Manual Compression
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Procedure: Standard Manual Compression
Closure procedure by Manual Compression
Active Comparator: AXERA 2 Access System
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Device: Vascular Access Device
AXERA 2 Access System with Reduced Manual Compression
Other Names:
  • AXERA 2 Access System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Any Site-Related Major Adverse Events
Time Frame: Up to 37 days post procedure
Observation of any major access site related complications (number of participants).
Up to 37 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AXERA 2 Access System Success
Time Frame: At the time of the femoral artey access procedure up to 1 hour post procedure
Achievement of femoral artery access with AXERA and placement of procedural sheath.
At the time of the femoral artey access procedure up to 1 hour post procedure
Time to Hemostasis
Time Frame: From procedural sheath removal until hemostasis is achieved.
Difference between the time the procedural sheath is removed and hemostasis is observed.
From procedural sheath removal until hemostasis is achieved.
Time to Discharge Eligibility
Time Frame: Up to 1 day post procedure
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Up to 1 day post procedure
Time to Actual Discharge
Time Frame: Up to 1 day post procedure
Time following procedural sheath removal until actual discharge.
Up to 1 day post procedure
Time to Ambulation
Time Frame: Up to 1 day post procedure
Time from sheath removal until the participant can stand or walk 20 feet without rebleeding. Ambulation can be evaluated at 1,2, and 4 hours post sheath removal until the participant can ambulate.
Up to 1 day post procedure
Ability to Sit up at 45-degree Angle
Time Frame: 15 minutes of successful hemostasis
The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
15 minutes of successful hemostasis
Minor Access Site Related Complications
Time Frame: Up to 37 days post procedure
Observation of any minor access site related complications.
Up to 37 days post procedure
Patient Satisfaction
Time Frame: Up to 37 days post procedure
Assessed by a patient satisfaction questionnaire.
Up to 37 days post procedure
Pain Score
Time Frame: Up to 37 days post procedure
Up to 37 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Frank Saltiel

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Borgess Medical Center
Borgess Cardiology Group
Borgess Heart Center for Excellence

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Frank Saltiel, MD, Chairman, Borgess Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRI-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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