InSeal Vascular Closure Device Clinical Study Protocol

Inclusion Criteria: * Candidate for large bore catheterization procedure (such as TAVI, aortic endograft repair) using a CE approved 18Fr access sheath. * Subject age is at least 18 years * Patient has signed most recent approved version of the Informed Consent * Existence of an additional arterial access port is required in instances where an occluding balloon is planned to be used as a safety precaution. Exclusion Criteria: * Women Of Child Bearing Potential (WOCBP) * Legally non-competent patients * Patient participating in another clinical study at the time of the InSeal VCD study * Prior target artery closure with a vascular closure device having intravascular component (such as Angio-Seal) 30 days prior to catheterization * Subjects with known coagulopathy, preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the vessel access site prior to artery closure * Patients that do not tolerate aspirin and clopidogrel anticoagulation treatment * Prior vascular surgery or vascular graft in region of access site * Significant calcification, atherosclerotic disease, or stent within 1.5 cm of the puncture site that may interfere with the operation of the experimental device