Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

Inclusion Criteria: * Scheduled for a coronary or peripheral diagnostic or interventional procedure * Able to undergo emergent vascular surgery if a complication requires it * 6F arterial puncture located in the common femoral artery * Femoral artery has a lumen diameter of at least 5 mm 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…