Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

Exclusion Criteria

• •Arterial puncture in the femoral artery of both legs
• •Prior target artery closure with any vascular closure device, or closure with manual compression within 30 days prior to catheterization
• •Patients who bruise or bleed easily or with a history of significant bleeding or platelet disorders
• •Acute ST-elevation myocardial infarction within 48 hours prior to catheterization
• •Uncontrolled hypertension at time of vessel closure
• •Elevated Activated Clotting Time at time of vessel closure
• •Ineligible for in-catheterization lab introducer sheath removal
• •Concurrent participation in another investigational device or drug trial
• •Thrombolytic therapy, bivalirudin, other thrombin-specific anticoagulants, or low molecular weight heparin within 24 hours prior to catheterization
• •Preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to femoral artery closure
• •Prior femoral vascular surgery or vascular graft in region of access site
• •Femoral artery is tortuous or requires an introducer sheath longer than 11 cm
• •Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site that would interfere with the operation of the experimental device
• •Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
• •Antegrade vascular puncture
• •Body Mass Index over 40 kg/m\^2
• •Symptomatic leg ischemia in the target limb including severe claudication or weak/absent pulse
• •Femoral artery diameter stenosis exceeding 50%
• •Pre-existing severe non-cardiac systemic disease or terminal illness
• •Planned arterial access at the same access site within 30 days of catheterization
• •Extended hospitalization (e.g. Coronary Artery Bypass Graft (CABG) surgery)
• •Pre-existing systemic or cutaneous infection
• •Prior use of an intra-aortic balloon pump through the arterial access site
• •Cardiogenic shock during or immediately following the catheterization
• •Patient is unable to ambulate at baseline
• •Patient is known or suspected to be pregnant or is lactating
• •Patient is unavailable for follow-up
• •Any angiographic or clinical evidence that the physician feels would place the patient at increased risk with the use of the experimental device