arteriotomy artery puncture
Conditions
Interventions
The name of the product being investigated is the PerQseal® + (plus) closure
device. The PerQseal®+ closure device will be used in conjunction
with CE marked PerQseal® *L* Introducer. The PerQseal®
Sponsors
Vivasure Medical Ltd
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 compliance. III. Clinically indicated for an endovascular procedure using a common femoral arteriotomy created by a 14 - 22 F sheath.
Exclusion criteria
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 severe liver disease), definite or potential coagulopathy, platelet count 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major vascular access site complications related to the PerQseal®+ Closure Device up to 1 month from implantation (inclusive), is non-inferior to the major device related complication rate associated with alternative large hole closure, derived from a recent focused literature review in an equivalent patient population. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of minor vascular access site complications directly related to the PerQseal®+ Closure Deviceup to 1 month from implantation (inclusive), (as per definitions).Performance: assessed by technical success rate for the PerQseal®+ Closure Device at discharge or within 5 days of implantation, is non-inferior than the technical success rates associated with alternative large hole closure devices, derived from a recent focused literature review in an equivalent patient population. | — |
Countries
Netherlands
Outcome results
None listed