Safety and Performance Study of Large Hole Vascular Closure Device FIV (NCT03423602) | Clinical Trial Compass
CompletedNot Applicable
Safety and Performance Study of Large Hole Vascular Closure Device FIV
Germany75 participantsStarted 2017-10-12
Plain-language summary
The purpose of this Clinical Investigation Plan (CIP) is to:
1. Confirm the safety and performance of the PerQseal® large hole closure system.
2. To expand its indications of use to include common femoral arteriotomies created with 12 to 20 F sheaths in patients undergoing endovascular procedures.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Over 18 years of age.
* Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
* Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 12 - 20 F sheath.
Exclusion Criteria:
* Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than six months.
* Evidence of systemic bacterial or cutaneous infection, including groin infection.
* Known bleeding diathesis, definite or potential coagulopathy, platelet count \< 100,000/μl or patients on long term anticoagulants with an INR greater than 1.2 at time of procedure or known type II heparin-induced thrombocytopenia.
* Severe; claudication or peripheral vascular disease (e.g. Rutherford category 3 or greater or ABI \< 0.5), documented untreated iliac artery diameter stenosis \> 50% or previous bypass surgery/stent placement in the common femoral artery of ipsilateral limb.
* Known allergy to any of the materials used in the PerQseal®.
* Subject has undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral target leg.
* Patients that have undergone a percutaneous procedure in the ipsilateral leg, within the previous 30 days.
* Patients that have undergone a percutaneous procedure using an absorbable intravascular closure device for haemostasis…