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18 to 24 F Percutaneous Femoral Arteriotomy Closure clinical trials

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NCT ID: NCT02788448 Recruiting - Clinical trials for 18 to 24 F Percutaneous Femoral Arteriotomy Closure

Safety and Performance Study of Large Hole Vascular Closure Device

Frontier III
Start date: January 2016
Phase: N/A
Study type: Interventional

The purpose of this Clinical Investigation is to validate that the clinical use of the VIVASURE CLOSURE DEVICEā„¢ is safe for the operator, patient and third parties, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures. This is a non-inferiority study based on safety. Safety will be assessed by incidence and severity of major complication rates directly related to the VIVASURE CLOSURE DEVICE up to 3 months from implantation is no worse than those associated with cut-down and sutured close.