Safety and Performance Study of Large Hole Vascular Closure Device

This study will be a prospective, multi-centred, non-randomized pilot study to investigate the safety and performance of the VIVASURE CLOSURE DEVICE™. 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.

Patient safety will be monitored closely by the Data Safety Monitoring Committee (DSMC). Safety data will be reported to the DSMC for every patient with a reported complication. The DSMC will adjudicate on the safety data to determine whether it is safe to continue enrolment.

Subjects shall have a 1, 3 and 12 month follow-up assessment. Safety data from the follow-ups will be assessed by the Data Safety Monitoring Committee.

This protocol will adopt the VARC-2 definitions for major vascular complication associated with closure of the access site.

This pilot study will enrol approximately 10 subjects. The study is designed to support a larger CE Mark study. As such, a study safety assessment will be complete when all patients have completed their 1 month follow-up assessment. The Data Safety Monitoring Committee (DSMC) will review all complications and recommend whether it is safe to proceed to the CE Mark study. All patients will continue to be followed at 1, 3 and 12 month follow-ups.

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.