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 concentration of fibrinogen to be less than 100 mg/dl * Patients in which the arteriotomy is less than 18 F or greater than 24 F * Known allergy to any of the materials used in the device * Currently enrolled in any other investigational clinical study, whereby the primary endpoint has not yet been achieved * Patients judged unsuitable for surgical repair of the access site * If puncture site is via a vascular graft * If there is any indication that the puncture has been made in the profunda femoris or located less than 10 mm above the profunda femoris * Patients with a common femoral artery lumen diameter of less than 7 mm * Patients that have a lower extremity amputation from the ipsilateral or contralateral limb * Patients that have undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral leg * Patients that have undergone a percutaneous procedure greater than 8 F in the ipsilateral leg, within the previous 90 days * Patients that have undergone a percutaneous procedure of 8 F or less using an absorbable intravascular closure device for haemostasis, in the ipsilateral leg, within the previous 90 days * Patients that have undergone a percutaneous procedure of 8 F or less using a suture mediated closure device for haemostasis, in the ipsilateral leg, within the previous 30 days * Patients that have undergone a percutaneous procedure of 8 F or less using manual/mechanical pressure for haemostasis in the ipsilateral leg, within the previous 30 days * Patients with an acute haematoma of any size, arteriovenous fistula or Pseudoaneurysm at the access site * Significant blood loss/transfusion during interventional procedure or within 20 days of procedure requiring transfusion of greater than 4 units of blood * Angiographic evidence of arterial laceration, dissection or stenosis within the external iliac or femoral artery before the use of the VCD * Severe claudication, stenosis of the iliac artery \> 50% or previous bypass surgery/stent placement in the region of the vascular access