Safety and Performance Study of Large Hole Vascular Closure Device (NCT01943344) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Study of Large Hole Vascular Closure Device
Ireland12 participantsStarted 2013-07
Plain-language summary
The purpose of this Clinical Investigation is to gather feasibility data on the clinical use of the VIVASURE CLOSURE DEVICE⢠in relation to safety, and to confirm its performance to percutaneously close femoral arterial puncture sites in the range of 18-24 F, post endovascular procedures.
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 ⤠12 months. A pregnancy test may be performed to confirm this.
Exclusion Criteria:
There will be no exclusion of patients from this trial in respect of race, co-existent disease or concomitant therapy, with the exception of those listed below.
* 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) and/or VRE (vancomycin-resistant Enterococci) colonisation.
* With arterial access other than the common femoral artery.\*
* Patients suffering with definitive or potential coagulopathy or platelet count less than 100,000/µl.
* Patient with a haematocrit of less than 32 %.
* 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 diameterā¦
What they're measuring
1
Major Vascular Complications Directly Related to Device