Safety and Performance Study of Large Hole Vascular Closure Device (NCT02788448) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Study of Large Hole Vascular Closure Device
Germany42 participantsStarted 2016-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Over 18 years of age.
* Each patient, or his or her guardian or legal representative, is willing to give informed consent.
* Clinically indicated for an endovascular procedure involving access through the femoral artery, with an access puncture of 18 - 24 F.
* Females who are not pregnant or lactating and not planning to become pregnant ā¤ 12 months. A pregnancy test may be performed to confirm this.
Exclusion Criteria:
* Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
* Evidence of systemic bacterial or cutaneous infection, including groin infection.
* Evidence of MRSA (Methicillin-resistant Staphylococcus aureus) colonisation.
* With arterial access other than the common femoral artery.\*
* Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/Āµl.
* Patient with a haematocrit of less than 30 %.
* A measured activated clotting time (ACT) of greater than 350 seconds immediately prior to sheath removal.\*
* If patients are expected to be continuously treated with anticoagulation therapy post-procedure such that their ACT reading is expected to be elevated above 350 seconds for more than 24 hours after the procedure.
* Evidence of arterial diameter stenosis greater than 20 % within 20 mm of the arteriotomy.\*
* Circumferential calcification within 20 mm of the arteriotomy.\*
* Use of systemic thrombolytic agents within 24 hours prior to or during the caā¦