A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

Inclusion criteria

• Patient is between 18 and 85 years of age.
• Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
• Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.

Exclusion criteria

• Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
• Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
• Patient has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mmHg diastolic).
• Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
• Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count <100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin< 10 g/dL, or Hct<30%).
• Patient has a compromised femoral artery access site.
• Patient procedure requires an introducer sheath size of> 6F.
• Patient has had prior vascular surgery or vascular grafts at the femoral artery access site.
• Patient presents with hemodynamic instability or is in need of emergent surgery.
• Patient has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days of the current procedure.
• Patient has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of< 30 dys or for other reasons has a life expectancy of less than 1 yaer.
• Patient is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
• Pregnant or lactating patients.