Mynx M5 One Hour Ambulation Study

Exclusion Criteria

• •Patient had a prior surgical procedure, PTA, stent placement, or vascular graft in the common femoral artery
• •Patient has a bleeding disorder such as thrombocytopenia
• •Patient has uncontrolled hypertension
• •Patient is morbidly obese (BMI \>40 kg/m2
• •Patient is pregnant or lactating
• •Patient has a documented INR \>1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitor
• •Patient has a known severe allergy to contrast medium
• •Patient has a known allergy to PEG
• •Patient is unable to ambulate at one hour secondary to a co-morbid condition
• •Patient is know to require an extended hospitalization or re-hospitalization (e.g.patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled to have a CABG surgery \<30 days following the procedure
• •Common femoral artery is \<5mm in diameter
• •Patient with clinically significant peripheral vascular disease in the vicinity of the puncture
• •Puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks
• •Patient has a posterior puncture or multiple punctures in an attempt to gain access
• •Patient has an ipsilateral venous sheath
• •Patient has a pre-existing arterial bleed/extravasation identified on pre-procedure femoral arteriogram, hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal
• •Patient has intra-procedural bleeding around the access site prior to sheath removal