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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Vascular Access Device
* Procedure: Standard Manual Compression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Manual Compression<br>Standard manual compression at the access site applied as per standard of care protocol for sheath removal. | Procedure: Standard Manual Compression<br>* Closure procedure by Manual Compression<br>|
| Active Comparator: AXERA 2 Access System<br>The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm. | Device: Vascular Access Device<br>* AXERA 2 Access System with Reduced Manual Compression<br>* Other names: AXERA 2 Access System;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Coronary Disease, Heart disease, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis, Manual Compression