AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial

Exclusion Criteria

• •Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the peripheral catheterization procedure
• •History of significant bleeding or with any known or documented bleeding disorders, such as thrombocytopenia (with \< 100,000 platelet count), von Willebrand disease, anemia (Hgb \< 10 g/Dl, Hct \< 30%), thrombasthenia, decreased fibrinogen (\< 200 mg/Dl), and Factor V deficiency
• •Acute ST-elevation myocardial infarction ≤ 48 hours prior to the peripheral catheterization procedure
• •Ineligible for introducer sheath removal
• •Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the peripheral catheterization procedure
• •Evidence of a preexisting hematoma, arteriovenous fistula, or pseudo-aneurysm at the access site prior to start of femoral artery closure procedure
• •Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery
• •Targeted femoral artery is tortuous or requires a sheath length \> 10 cm
• •Pregnant or lactating
• •Mean body mass index (BMI) \> 35 kg/m²
• •Existing nerve damage in ipsilateral limb
• •Fibrotic, heavily calcified femoral artery within 10mm of the entry point
• •Non-palpable pulses in affected access limb
• •Difficult insertion of procedural sheath, needle stick problems at the onset of the peripheral procedure or difficult insertion of ABS 5.6.7
• •Procedural sheath placement either through superficial femoral artery or into the profunda femoris artery or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery
• •Common femoral artery (CFA) puncture site located above the lowest sweep of the inferior epigastric artery; referred to as a "high stick"
• •Common femoral artery (CFA) access puncture site located on the front wall that continues through the back wall of the targeted vessel; referred to as a "back wall stick"
• •Common femoral artery (CFA) access puncture site with multiple punctures of the CFA in an attempt to gain access to the targeted vessel known as "multiple sticks"
• •Common femoral artery (CFA) access puncture located in the side wall region of the targeted access vessel; referred to as a "side wall stick"
• •Interventional procedures with multiple exchanges during the procedure that cause elongation and trauma to the vessel compromising the tight seal between the vessel and the sheath
• •Hematoma developing during the course of the percutaneous procedure