Safety and Performance Study of Large Hole Vascular Closure Device

Inclusion Criteria: * Over 18 years of age * Each patient, or his or her guardian or legal representative, is willing to give informed consent * Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 French (F) * Females who are not pregnant or lactating, and not planning to become pregnant in ≤ 12 months Exclusion Criteria: * Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year * Evidence of systemic bacterial or cutaneous infection * Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation * Arterial access other than the common femoral artery * Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/μl * Patient with a haematocrit of less than 32 % * A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal * If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure * Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy * Circumferential calcification within 20 mm of the arteriotomy * Use of systemic thrombolytic agents within 24 hours prior to or during the catheterisation procedure which cause the concen…