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

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.

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.

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.