Safety and Performance Study of Large Hole Vascular Closure Device - France (NCT05323877) | Clinical Trial Compass
UnknownNot Applicable
Safety and Performance Study of Large Hole Vascular Closure Device - France
20 participantsStarted 2022-05
Plain-language summary
This study will be a prospective, multi-centred, non-randomized study to investigate the safety and performance of the PerQseal® + in up to 20 patients in 2 centres within France. 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 - 22 F sheaths (arteriotomy up to 26 F).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
i. Over 18 years of age. ii. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
iii. Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 14 - 22 F sheath.
General Exclusion Criteria:
i. Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than four months.
ii. Evidence of systemic bacterial or cutaneous infection, including groin infection.
iii. 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.
iv. Previous groin surgery within the region of the ipsilateral access. v. 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.
vi. Known allergy to any of the materials used in the PerQseal® + or PerQseal® Introducer (refer to Investigator's Brochure for materials list).
vii. Subject has undergone a percutaneous procedure using a non-absorbable vascular closure device (excluding suture mediated) for haemostasis in the ipsilateral target leg.
viii. Patient…