This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 90 patients in up to 8 European investigational sites. The PerQseal® + shall be indicated for the percutaneous closure of femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created with 14 - 22F sheaths (arteriotomy up to 26 F).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 14 - 22 F sheath.
General Exclusion Criteria:
* Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than four months.
* Evidence of systemic bacterial or cutaneous infection, including groin infection.
* Known bleeding diathesis (including sever liver disease), definite or potential coagulopathy, platelet count \< 100,000/µl or patients on long term anticoagulants with an INR greater than 2 at time of procedure or known type II heparin-induced thrombocytopenia.
* Previous groin surgery within the region of the ipsilateral access.
* 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® + or PerQseal® Introducer (refer to Investigator's Brochure for materials list).
* 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 percuta…