Clinical trial NCT02061696: ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
Official title: A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Coronary Disease
Heart disease
Cardiovascular Diseases
Arteriosclerosis
Atherosclerosis
Manual Compression
Lead sponsor: Borgess Research Institute
Sponsor class: OTHER
Collaborators: name: Borgess Medical Center
name: Borgess Cardiology Group
name: Borgess Heart Center for Excellence
First posted: 2014-02-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Number of Participants With Any Site-Related Major Adverse Events
timeFrame: Up to 37 days post procedure
Secondary outcomes:
measure: AXERA 2 Access System Success
timeFrame: At the time of the femoral artey access procedure up to 1 hour post procedure
measure: Time to Hemostasis
timeFrame: From procedural sheath removal until hemostasis is achieved.
measure: Time to Discharge Eligibility
timeFrame: Up to 1 day post procedure
measure: Time to Actual Discharge
timeFrame: Up to 1 day post procedure
measure: Time to Ambulation
timeFrame: Up to 1 day post procedure
measure: Ability to Sit up at 45-degree Angle
timeFrame: 15 minutes of successful hemostasis
measure: Minor Access Site Related Complications
timeFrame: Up to 37 days post procedure
measure: Patient Satisfaction
timeFrame: Up to 37 days post procedure
measure: Pain Score
timeFrame: Up to 37 days post procedure
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
Study officials:
affiliation: Chairman, Borgess Heart Institute
name: Frank Saltiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.