To assess safety and performance of the PerQseal® + Closure Device when used with the L PerQseal®Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The rapid development of percutaneous *minimal invasive therapy* in which
multiple disciplines are involved including Vascular Surgery, Cardiac
Surgery, Interventional Radiology and Interventional Cardiology, has led
to the need for instrumentation to minimise the risk of complications
associated with closing the access site, post procedure. The currently
emerging endovascular or transcatheter procedures include: Aortic Valve
Replacement, Mitral Valve Repair and Abdominal and Thoracic Aneurysm Repair.
These procedures require larger size access sites up to 26 French (F). These
large access sites are typically created via surgical cut-down to
the common femoral artery and closed by surgical repair. In order to provide
a less invasive, percutaneous, safe, secure and simple mechanical closure of
these large arteriotomies and shorten the time taken to perform these
closures, Vivasure is developing a new large hole percutaneous vascular closure
device to induce arterial haemostasis in patients undergoing
endovascular interventional therapeutic procedures created with sheath sizes
14 -22 F(arteriotomy up to 26 F).
Study objective
To assess safety and performance of the PerQseal® + Closure Device when used
with the L PerQseal®Introducer to percutaneously close femoral artery punctures
and to induce arterial haemostasis in patients undergoing endovascular
procedures requiring an arteriotomy created by 14 to 22 F sheaths. Note for
reference purposes it is expected arteriotomies created with14 to 22 F sheaths
will create an arteriotomy in the range of 16 -26 F (being the outer diameter
of these sheaths).
*Note: The PerQseal®*L* Introducer is currently CE marked for use with the
PerQseal®Closure Device.The PerQseal®closure device is indicated for the
percutaneous sealing of a common femoral arteriotomy in patients
following interventional therapeutic endovascular procedures (post primary
procedures requiring sheaths in the range of 12-20 F).
Study design
This study will be a prospective, multi-centred, non-randomized study to
investigate the safety and performance of the PerQseal®+. The study shall not
be blinded prior to, during or post the procedure. All patients undergoing an
endovascular procedure requiring an arteriotomy createdby 14 to 22 F
sheaths, via the common femoral artery will be screened against the
inclusion/exclusion criteria. Closures may be performed by either
clinical specialty, namely;Interventionalist or Vascular Surgeon. Patients
with bilateral percutaneous access in the common femoral arteries where both
arteries meet all eligibility criteria may, at the discretion of the
investigator, both be closed with the PerQseal®+ closure device. If a PerQseal®
+ is used on the contralateral femoral artery then this will be treated as an
independent closure.All subjects shall have a 1- and 3-month follow-up
assessment. All safety data from the studywill be assessed by the Data Safety
Monitoring Committee on a continuous basis
Intervention
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® *L* Introducer is
currently CE marked for use with the PerQseal® closure device. The PerQseal®
+is a percutaneous vascular closure device designed specifically for
large hole arteriotomies. The PerQseal®+ product consists of an absorbable
Implant, a Delivery system, Introducer and the associated packaging (inclusive
of labelling).
The vascular closure device (VCD) consist of an absorbable implant consisting
of both intra-arterial and extra-arterial components, namely the Scaffold,
Patch, and Extra-arterial-locator. The Scaffold and Extra-arterial-locator are
also identical to the already CE marked PerQseal product. There has been a
change in the size and shape of the Patch component of the PerQseal®+ implant
to facilitate closure of arteriotomies up to 26 Fr.
The PerQseal® + implant is designed to achieve a secure and rapid seal of the
access site at conclusion of the endovascular procedure, with implant
absorption within 180 days.
Study burden and risks
For the patients involved in this study, the potential advantages of the
PerQseal® + over surgical access and sutured closure include the following:
• Less invasive percutaneous sealing of arteriotomy compared to surgical cutdown
• Implant is fully absorbed, leaving nothing permanent behind
• Minimal procedural steps required to achieve haemostasis
• Safe and Effective sealing of the puncture site for subjects treated with
anticoagulation therapy, antiplatelet agents, intravenous glycoprotein IIb /IIIa
inhibitors, or thrombolytic agents
• Delivered and deployed at the conclusion of the primary procedure
(minimisation
of steps for access in emergency procedures)
• Percutaneous arterial wire access maintained during the PerQseal® + Closure
Device delivery
• Minimisation of the temporary disruption of arterial flow, which occurs with
arterial
clamping during surgical closure
• Implant is fully removable from the patient (whilst it is attached to the
delivery
system) after the sealing has been confirmed at the tamponade phase with the
implant in its in situ position at the arteriotomy, whilst maintaining
percutaneous
access via the guidewire.
Taking part in this study can have these cons:
• Patient may experience the side effects or adverse effects of
medical device as detailed in section E9
• There may be some discomfort from the measurements during the
study.
• Taking part in the study will cost extra time.
• Patient has to comply with the study agreements.
In addition to those listed above there may be unforeseeable risks, which are
not known at this time
All patients should have a scheduled follow-up at discharge and 1 and 3 month
post-procedure (with a tolerance of -7/+14 days for 1 month follow-up). Due to
COVID-19 restrictions or other reasons subjects may not be able to return for
all scheduled visits, therefore follow-up at 1 month & 3 months may be
completed over the phone
Parkmore Business Park West 00
Galway H91 V3KP
IE
Parkmore Business Park West 00
Galway H91 V3KP
IE
Listed location countries
Age
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
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnumberwillbeobtainedbeforestudystart |
| CCMO | NL76181.000.21 |