Safety and Performance Study of Large Hole Vascular Closure Device - Frontier V study
- Conditions
- arteriotomyartery puncture10003184
- Registration Number
- NL-OMON50786
- Lead Sponsor
- Vivasure Medical Ltd
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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
compliance.
III. Clinically indicated for an endovascular procedure using a common femoral
arteriotomy created by a 14 - 22 F sheath.
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 severe 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. Patients that have undergone a percutaneous procedure in the ipsilateral
leg, within the previous 30 days.
IX. Patients that have undergone a percutaneous procedure using an absorbable
intravascular closure device for haemostasis, in the ipsilateral leg, within
the previous 90 days.
X. Evidence of arterial diameter stenosis > 20% or anterior or circumferential
calcification within 20 mm proximal or distal to target arteriotomy site based
on pre-procedure CT angiography.
XI. Females who are pregnant or lactating or in fertile period not taking
adequate contraceptives. A pregnancy test may be performed.
XII. Patients that have a lower extremity amputation from the ipsilateral or
contralateral limb.
XIII. Target puncture site is located in a vascular graft.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of major vascular access site complications related to the PerQseal®+<br /><br>Closure Device up to 1 month from implantation (inclusive), is non-inferior to<br /><br>the major device related complication rate associated with alternative large<br /><br>hole closure, derived from a recent focused literature review in an equivalent<br /><br>patient population.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety: Incidence of minor vascular access site complications directly related<br /><br>to the PerQseal®+ Closure Deviceup to 1 month from implantation (inclusive),<br /><br>(as per definitions).Performance: assessed by technical success rate for the<br /><br>PerQseal®+ Closure Device at discharge or within 5 days of implantation, is<br /><br>non-inferior than the technical success rates associated with alternative large<br /><br>hole closure devices, derived from a recent focused literature review in an<br /><br>equivalent patient population.</p><br>