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

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: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Standard Manual Compression; Device: Vascular Access Device

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: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of Participants With Any Site-Related Major Adverse Events	Observation of any major access site related complications (number of participants).	Up to 37 days post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AXERA 2 Access System Success	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	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	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 following procedural sheath removal until actual discharge.	Up to 1 day post procedure
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.	Up to 1 day post procedure
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.	15 minutes of successful hemostasis
Minor Access Site Related Complications	Observation of any minor access site related complications.	Up to 37 days post procedure
Patient Satisfaction	Assessed by a patient satisfaction questionnaire.	Up to 37 days post procedure
Pain Score		Up to 37 days post procedure

Collaborators and Investigators

• Sponsor: Frank Saltiel
• Collaborators: Borgess Medical Center; Borgess Cardiology Group; Borgess Heart Center for Excellence
• Investigators: Principal Investigator: Frank Saltiel, MD, Chairman, Borgess Heart Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: January 30, 2014
• First Submitted That Met QC Criteria: February 11, 2014
• First Posted (Estimate): February 13, 2014

Study Record Updates

• Last Update Posted (Actual): May 23, 2018
• Last Update Submitted That Met QC Criteria: April 23, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Coronary Artery Disease; Atherosclerosis; Heart disease; Arteriosclerosis; Coronary Disease; Manual Compression
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: BRI-001