Back to resultsARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System (ARISTOCRAT)
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vascular Access Device
Standard Manual Compression
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Coronary Disease, Heart disease, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis, Manual Compression
Eligibility Criteria
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.
Sites / Locations
- Borgess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Manual Compression
AXERA 2 Access System
Arm Description
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Outcomes
Primary Outcome Measures
Number of Participants With Any Site-Related Major Adverse Events
Observation of any major access site related complications (number of participants).
Secondary Outcome Measures
AXERA 2 Access System Success
Achievement of femoral artery access with AXERA and placement of procedural sheath.
Time to Hemostasis
Difference between the time the procedural sheath is removed and hemostasis is observed.
Time to Discharge Eligibility
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Time to Actual Discharge
Time following procedural sheath removal until actual discharge.
Time to Ambulation
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.
Ability to Sit up at 45-degree Angle
The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
Minor Access Site Related Complications
Observation of any minor access site related complications.
Patient Satisfaction
Assessed by a patient satisfaction questionnaire.
Pain Score
Full Information
NCT ID
NCT02061696
First Posted
January 30, 2014
Last Updated
April 23, 2018
Sponsor
Frank Saltiel
Collaborators
Borgess Medical Center, Borgess Cardiology Group, Borgess Heart Center for Excellence
1. Study Identification
Unique Protocol Identification Number
NCT02061696
Brief Title
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
Acronym
ARISTOCRAT
Official Title
A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Why Stopped
Device was modified and no longer available to investigator
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Frank Saltiel
Collaborators
Borgess Medical Center, Borgess Cardiology Group, Borgess Heart Center for Excellence
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Coronary Disease, Heart disease, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis, Manual Compression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Manual Compression
Arm Type
Active Comparator
Arm Description
Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Arm Title
AXERA 2 Access System
Arm Type
Active Comparator
Arm Description
The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Intervention Type
Device
Intervention Name(s)
Vascular Access Device
Other Intervention Name(s)
AXERA 2 Access System
Intervention Description
AXERA 2 Access System with Reduced Manual Compression
Intervention Type
Procedure
Intervention Name(s)
Standard Manual Compression
Intervention Description
Closure procedure by Manual Compression
Primary Outcome Measure Information:
Title
Number of Participants With Any Site-Related Major Adverse Events
Description
Observation of any major access site related complications (number of participants).
Time Frame
Up to 37 days post procedure
Secondary Outcome Measure Information:
Title
AXERA 2 Access System Success
Description
Achievement of femoral artery access with AXERA and placement of procedural sheath.
Time Frame
At the time of the femoral artey access procedure up to 1 hour post procedure
Title
Time to Hemostasis
Description
Difference between the time the procedural sheath is removed and hemostasis is observed.
Time Frame
From procedural sheath removal until hemostasis is achieved.
Title
Time to Discharge Eligibility
Description
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Time Frame
Up to 1 day post procedure
Title
Time to Actual Discharge
Description
Time following procedural sheath removal until actual discharge.
Time Frame
Up to 1 day post procedure
Title
Time to Ambulation
Description
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.
Time Frame
Up to 1 day post procedure
Title
Ability to Sit up at 45-degree Angle
Description
The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
Time Frame
15 minutes of successful hemostasis
Title
Minor Access Site Related Complications
Description
Observation of any minor access site related complications.
Time Frame
Up to 37 days post procedure
Title
Patient Satisfaction
Description
Assessed by a patient satisfaction questionnaire.
Time Frame
Up to 37 days post procedure
Title
Pain Score
Time Frame
Up to 37 days post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Saltiel, MD
Organizational Affiliation
Chairman, Borgess Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23293169
Citation
Turi ZG, Wortham DC, Sampognaro GC, Kresock FD, Held JS, Smith RD, Veerina KK, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial. J Invasive Cardiol. 2013 Jan;25(1):13-8.
Results Reference
background
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ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
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