Safety and Performance Study of Large Hole Vascular Closure Device

Safety and Performance Study of Large Hole Vascular Closure Device - FRONTIER II Study

The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICE™ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.

This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation is no worse than those associated with cut-down and sutured close.

This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. The study shall not be blinded prior to, during or post the procedure. All patients undergoing a procedure requiring an arteriotomy in the range of 18 to 24 F, via the common femoral artery will be screened against the inclusion/exclusion criteria. If the patient meets the requirements of the clinical investigation, they shall be invited to participate, provide informed consent and shall subsequently be assigned a subject number.

All subjects shall have an immediately post procedure, 24 hour, 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.

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