Mynx M5 One Hour Ambulation Study

Key Inclusion:

• Patients >18 yrs of age
• Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery.
• Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.

Inclusion criteria

• Patient is > 18 years of age
• Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
• Patient has been informed and understands the nature of the study and provides written INformed COnsent approved by the appropriate Institutional Review Board (IRB) prior to enrollment
• Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by the investigator

Exclusion criteria

Pre-Procedure 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

Intra-Procedure Exclusion Criteria

• 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