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

Inclusion Criteria:

• Over 18 years of age.
• Subject is willing and able to provide appropriate study-specific informed consent,follow protocol procedures, and comply with follow-up visit requirements.
• Clinically indicated for an endovascular procedure using a common femoral arteriotomycreated by a 14 - 22 F sheath.

General Exclusion Criteria:

• Severe acute non-cardiac systemic disease or terminal illness with a life expectancyof less than four months.
• Evidence of systemic bacterial or cutaneous infection, including groin infection.
• Known bleeding diathesis (including sever liver disease), definite or potentialcoagulopathy, platelet count < 100,000/µl or patients on long term anticoagulants withan INR greater than 2 at time of procedure or known type II heparin-inducedthrombocytopenia.
• Previous groin surgery within the region of the ipsilateral access.
• Severe; claudication or peripheral vascular disease (e.g. Rutherford category 3 orgreater or ABI < 0.5), documented untreated iliac artery diameter stenosis > 50% orprevious bypass surgery/stent placement in the common femoral artery of ipsilaterallimb.
• Known allergy to any of the materials used in the PerQseal® + or PerQseal® Introducer (refer to Investigator's Brochure for materials list).
• Subject has undergone a percutaneous procedure using a non-absorbable vascular closuredevice (excluding suture mediated) for haemostasis in the ipsilateral target leg.
• Patients that have undergone a percutaneous procedure in the ipsilateral leg, withinthe previous 30 days.
• Patients that have undergone a percutaneous procedure using an absorbableintravascular closure device for haemostasis, in the ipsilateral leg, within theprevious 90 days.
• Evidence of arterial diameter stenosis > 20% or anterior or circumferentialcalcification within 20 mm proximal or distal to target arteriotomy site based onpre-procedure CT angiography.
• Females who are pregnant or lactating or in fertile period not taking adequatecontraceptives. A pregnancy test may be performed.
• Patients that have a lower extremity amputation from the ipsilateral or contralaterallimb.
• Target puncture site is located in a vascular graft. Procedural Exclusion Criteria:
• Arterial access other than common femoral artery obtained for ipsilateral target leg.
• Subject has a tissue tract expected to be greater than 10 cm.
• Significant blood loss/transfusion (defined as requiring transfusion of 4 or moreunits of blood products) during index procedure or within 30 days prior to indexprocedure.
• Unstable blood pressure or heart rate, symptoms of shock or systolic blood pressuregreater than 160 mmHg (maybe controlled by pacing or pharmacologically eg. vasodilatorsuch as nitrates etc.).
• Activated clotting time (ACT) > 350 seconds immediately prior to sheath removal or ifACT measurements are expected to be > 350 seconds for more than 24 hours after indexprocedure.
• Target arteriotomy is in the profunda femoris or superficial femoral artery or is incommon femoral artery, but within 15 mm proximal of the bifurcation of the SuperficialFemoral /Profunda Femoris artery.
• PerQseal® Introducer-sheath to ipsilateral femoral artery diameter ratio is greaterthan or equal to 1.05. (vessel lumen diameter of less than 7 mm.)
• Subjects with an acute haematoma of any size, arteriovenous fistula or pseudoaneurysmat the target access site; or any evidence of arterial laceration or dissection withinthe external iliac or femoral artery before the use of the PerQseal® + Closure Device.
• Use of thrombolytic agents within 24 hours prior to or during the endovascularprocedure which causes fibrinogen < 100 mg/dl.