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

Coronary Artery Disease Clinical Trial

— ARISTOCRAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02061696
• Other study ID #: BRI-001
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: April 2018
• Source: Borgess Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Vascular Access Device
AXERA 2 Access System with Reduced Manual Compression

Procedure:
• Standard Manual Compression
Closure procedure by Manual Compression

Locations

Country	Name	City	State
United States	Borgess Medical Center	Kalamazoo	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Frank Saltiel	Borgess Cardiology Group, Borgess Heart Center for Excellence, Borgess Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to Hemostasis	Difference between the time the procedural sheath is removed and hemostasis is observed.	From procedural sheath removal until hemostasis is achieved.
Secondary	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
Secondary	Time to Actual Discharge	Time following procedural sheath removal until actual discharge.	Up to 1 day post procedure
Secondary	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
Secondary	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
Secondary	Minor Access Site Related Complications	Observation of any minor access site related complications.	Up to 37 days post procedure
Secondary	Patient Satisfaction	Assessed by a patient satisfaction questionnaire.	Up to 37 days post procedure
Secondary	Pain Score		Up to 37 days post procedure