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 F.
• Females who are not pregnant or lactating, and not planning to become pregnant ≤ 12 months. A pregnancy test may be performed to confirm this.

Exclusion Criteria

There will be no exclusion of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below.

• 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, including groin infection.
• Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) and/or VRE (vancomycin-resistant Enterococci) colonisation.
• With 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 (Refer to Instructions for Use).
• Currently enrolled in any other investigational clinical study, where 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 an access site 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 prior to 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.*
• May not be known until after the patient has given informed consent and the procedure has started.