PerQseal®+ Early Feasibility Study

Exclusion criteria

• ✕. Evidence of systemic bacterial or cutaneous infection, including groin infection,
• ✕. Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/µl or subjects on long term anticoagulants with an INR \> 2 within 12 hours prior to index procedure,
• ✕. Significant anemia (hemoglobin \< 9 g/dL or hematocrit \< 27%), within 24 hours prior to index procedure,
• ✕. Known type II heparin-induced thrombocytopenia,
• ✕. NYHA functional class IV heart failure that is uncontrolled and requires treatment in the Intensive Care Unit, within 24 hours prior to primary procedure,
• ✕. Documented left ventricular ejection fraction \< 20%,
• ✕. Unilateral or bilateral lower extremity amputation.
• ✕. Claudication (e.g., Rutherford category 3 or greater), documented untreated iliac or common femoral artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of target leg,