To assess safety and performance of the PerQseal Elite Closure Device when used with the 18F PerQseal Elite Introducer to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Safety Endpoint: The primary safety endpoint is the rate of major
access site complications attributable to the PerQseal Elite device through
30-days, as adjudicated by an independent Clinical Events Committee (CEC). The
endpoint is a composite comprised of the following elements: 1. Access
site-related bleeding due to a failure of the PerQseal Elite device that
requires transfusion of blood product(s), or 2. Device-related vascular injury
that requires surgical repair or percutaneous stent-graft placement, or 3. Any
new and sustained (longer than 24 hrs) device-related ipsilateral lower
extremity ischemia documented by patient symptoms, physical exam, and/or
decreased or absent blood flow on lower extremity angiogram, which causes a
threat to the viability of the limb, and/or requires surgical repair or
additional percutaneous intervention, or 4. Surgery for device-related nerve
injury, or 5. Permanent (lasting to 30-days) device-related nerve injury, or 6.
Access site infection requiring intravenous antibiotics, drainage and/or
extended hospitalisation. Primary Effectiveness Endpoint: The Primary
effectiveness endpoint is the elapsed time in minutes from PerQseal Elite
(Introducer-sheath and Delivery Device) removal from the patient to first
observed cessation of common femoral artery (CFA) bleeding, excluding cutaneous
or subcutaneous oozing, and in the absence of a developing haematoma.
Secondary outcome
Safety: Incidence of minor vascular access site complications attributable to
the PerQseal Elite Closure Device through 30-days from implantation
(inclusive), (as per definitions).
Effectiveness: assessed by technical success rate for the PerQseal Elite
Closure Device at discharge or within 5 days of implantation, is non-inferior
to a Technical Success Performance Goal derived from a recent focused
literature review in an equivalent patient population of the technical success
rates associated with alternative large hole closure devices.
Other parameters that will be reported are: PerQseal Elite Treatment Success
Rate, Time to Device Deployment, Total Closure Time, Time to Ambulation,
Incidence of Major Access Site Complications per VARC-3 and Incidence of Minor
Access Site Complications per VARC-3.
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. Examples of currently emerging percutaneous
catheter- based procedures include: Aortic Valve Replacement, Mitral Valve
Repair, Tricuspid Valve Replacement, Abdominal and Thoracic Aneurysm Repair,
Left Ventricular Circulatory Assist and Extracorporeal Membrane Oxygenation.
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 has developed a family of PerQseal closure
devices (PerQseal, PerQseal+ and now PerQseal Elite). The PerQseal closure
technology are large hole percutaneous vascular closure devices to induce
arterial haemostasis in patients undergoing endovascular interventional
therapeutic procedures created with sheath sizes 12 - 22 F (arteriotomy up to
26 F).
The PerQseal Elite has a similar delivery device and mode of operation to both
PerQseal and PerQseal+ and similar implant to that of the PerQseal+, however,
it is designed with several user interface improvements. Significantly, the
PerQseal Elite is designed to be delivered over a 0.035* guidewire (compared to
the 0.014* guidewire used with the PerQseal and PerQseal+ devices), this
facilitates use of the primaryprocedure guidewire and eliminates the need for a
guidewire exchange to use the Elite device. Other improvements are the addition
of a sidearm to the PerQseal Elite sheath for flushing, better blood signalling
and blood loss control. Material changes were also made to the device handle
components to aid functionality and user experiences. There are no changes to
the implant material or methods of manufacture to those of the PerQseal or
PerQseal+ devices.
The PerQseal Elite is a natural extension to the PerQseal family of devices,
designed to improve the usability and user interface. These improvements were
driven by user feedback and not from any safety issues or concerns from use of
either the PerQseal or PerQseal+ devices.
Study objective
To assess safety and performance of the PerQseal Elite Closure Device when used
with the 18F PerQseal Elite 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 with 14 to
22 F sheaths will create an arteriotomy in the range of 16 - 26 F (being the
outer diameter of these sheaths).
Study design
This study will be a prospective, multi-centred, non-randomized study to
investigate the safety and performance of the PerQseal Elite. The study shall
not be blinded prior to, during or post the procedure. All patients undergoing
an endovascular procedure requiring an arteriotomy created by 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, have both arteries closed with the PerQseal Elite closure device.
If a PerQseal Elite is used on the contralateral femoral artery then this will
be treated as an independent closure.
All subjects shall have a pre-discharge, 30-Days ± 7-Days and 180-Days ±
30-Days follow-up assessment. All safety data from the study will be assessed
by the Data Safety Monitoring Committee on a continuous basis. Details of
follow-up assessments are contained in Table 10-1 of the protocol.
Intervention
The name of the product being investigated is the PerQseal® Elite Closure
Device. PerQseal® Elite Closure Device will be ised in conjunction with the 18F
PerQseal® Elite Introducer. The PerQseal Elite is a vascular closure device
designed specifically for large hole arteriotemies. The PerQseal Elite 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, External Fixation and Pin.
The PerQseal Elite is designed to achieve a secure and rapid seal of the
puncture site at conclusion of the procedure with implant absorption within
180-days
Study burden and risks
The following potential benefits associated with use of the PerQseal Elite for
access site closure may include, but are not limited to, the following:
• Less invasive percutaneous access and sealing of arteriotomy compared to
surgical cutdown and closure,
• Implant is fully bioabsorbed, leaving nothing permanent in the patient,
• Reduced pain and discomfort as compared to surgical access,
• Minimisation of secondary interventions to control bleeding,
• Percutaneous closure leads to shorter overall procedure time,
• Percutaneous procedure has lower major complications rates than cut-down
access/surgical closure,
• Ability to seal 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,
• Guidewire access maintained throughout the device delivery,
• Minimisation of the temporary disruption of arterial blood flow, which occurs
with arterial clamping during surgical closure,
• Reduction in scarring compared to surgical cut-down.
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, 1 month
post-procedure and 6 months post-procedure (with a tolerance of +/- 7 days for
1 month follow-up and +/- 30 days for 6 months follow-up).
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Listed location countries
Age
Inclusion criteria
1. Age >= 19 years,
2. Clinically indicated for a percutaneous arterial interventional
catheter-based procedure, e.g., transcatheter aortic valve
replacement/implantation (TAVR/TAVI) or endovascular abdominal aortic aneurysm
repair (EVAR), or thoracic endovascular aortic aneurysm repair (TEVAR), or use
of a circulatory assist device or extracorporeal oxygenation using a common
femoral arteriotomy created by a 14 to 22 F sheath (arteriotomy up to 26 F),
3. Subject is willing and able to provide appropriate study-specific informed
consent, follow protocol procedures, and comply with follow-up visit
requirements,
4. Females who are not pregnant or lactating and not planning to become
pregnant for the duration of the study.
Exclusion criteria
Baseline Exclusion Criteria:
1. Evidence of current systemic bacterial or cutaneous infection, including
groin infection,
2. Known bleeding diathesis, definite or potential coagulopathy, platelet count
lower than 100,000/µl or subjects on long term anticoagulants with an INR
higher than 2 within 12 hours prior to index procedure,
3. Significant anaemia (example: haemoglobin lower than 9 g/dL or haematocrit
lower than 27%), within 24 hours prior to index procedure,
4. Known type II heparin-induced thrombocytopenia,
5. Documented left ventricular ejection fraction lower than 20%,
6. Ipsilateral or contralateral lower extremity amputation,
7. Previous groin surgery within the region of the ipsilateral access,
8. Claudication (Rutherford category 3 or greater), documented untreated iliac
or common femoral artery diameter stenosis greater than 50% or previous bypass
surgery/stent placement in the common femoral artery of target leg,
9. Known existing nerve damage in the target leg,
10.Renal insufficiency (Glomerular Filtration Rate <= 30 ml/min or baseline
serum creatinine higher than 2.5 mg/dl) or on renal replacement therapy,
11. Known allergy to any of the materials used in the PerQseal Elite device
(refer to Investigator*s Brochure),
12. Subject is unsuitable for surgical repair of the target leg access site,
13. Subject has undergone a percutaneous procedure greater than 8F sheath in
the target leg, within the 90-days prior to index procedure,
14. Subject has undergone a percutaneous procedure of 8F sheath or less using
an absorbable intravascular closure device for haemostasis, in the target leg,
within the 90-days prior to index procedure,
15. Subject has undergone a percutaneous procedure of 8F sheath or less using a
suture mediated closure device or manual/mechanical pressure for haemostasis in
the target leg, within the 30-days prior to index procedure,
16. Evidence of marked tortuosity of the femoral or external iliac arteries in
the target leg, based on pre-primary procedure CT angiography,
17. Evidence of arterial diameter stenosis greater than 20% within 15 mm
proximal or distal to arteriotomy site based on pre-primary procedure CT
angiography,
18. Evidence of anterior wall calcification of the target common femoral artery
(other than small, diffuse deposits which in the opinion of the investigator
will not impede the vascular closure procedure) within 15 mm proximal or distal
to arteriotomy site based on pre-primary procedure CT angiography,
19. Target femoral artery diameter is less than 7 mm, based on pre-primary
procedure CT angiography,
20. Further planned endovascular/catheter-based procedure in the target leg in
the 30- days following the index procedure,
21. Subject is enrolled in another investigational medical device or drug
study,
22. Subject has been previously enrolled in this clinical study,
23. Current COVID-19 infection (with or without symptoms), recent positive test
for COVID- 19 within two weeks, or recent exposure to a person with COVID-19
infection within two weeks.
Procedural Exclusion Criteria*:
24. Initial common femoral arterial access achieved with manual palpation or
blind arterial stick access, without use of an image guided approach
(ultrasound or angiography),
25. Difficult dilation during initial target femoral artery access (e.g., that
damages or kinks dilators) while step-dilating up to the large-bore device,
26. During arterial puncture, the target femoral artery suspected to have
experienced a posterior arterial wall needle puncture or underwent more than
one needle puncture during the primary procedure, with a needle larger than a
micropuncture needle (greater than 21 gauge or greater than 0.819 mm in
diameter). (Note: not an exclusion if micropuncture technique under ultrasound
guidance used for femoral artery access ),
27. Subject has a tissue tract (i.e., estimated distance from skin entry point
to arterial anterior surface at arteriotomy) expected to be greater than 8 cm,
28. Significant blood loss requiring transfusion of blood products during
primary procedure or within 30-days prior to index procedure,
29. Activated clotting time (ACT) more than 300 seconds immediately prior to
sheath removal or if ACT measurements are expected to be more than 300 seconds
for more than 24 hours after index procedure,
30. Target puncture site is in a vascular graft,
31. Target arteriotomy greater than 26F,
32. Target arteriotomy in the profunda femoris or superficial femoral artery or
is in common femoral artery, but within 15 mm proximal of the bifurcation of
the superficial femoral/ profunda femoris artery, (apex of bifurcation
overlying the femoral head),
33. Target arteriotomy located at the level or above the inferior epigastric
artery and/or beneath or above the inguinal ligament based on bony/arterial
landmarks (above femoral head on A-P projection),
34.Subjects with an acute haematoma larger than 4 cm diameter, arteriovenous
fistula, pseudoaneurysm or intraluminal thrombosis at the target access site
identified intra- procedurally,
35. Evidence of bleeding around the primary procedure sheath (VARC type 1/BARC
type 2 or higher),
36. Intra-procedural angiographic evidence of arterial laceration, dissection
or stenosis within the femoral artery that would preclude use of the PerQseal
Elite device,
37. Uncontrolled hypertension (systolic blood pressure higher than 180 mmHg or
diastolic blood pressure higher than 110 mmHg) at the time of planned vascular
closure,
38. Systolic blood pressure lower than 90 mmHg at the time of planned vascular
closure.
*May not be known until after the patient has given informed consent and the
procedure has started. In this event, the PerQseal Elite should not be used and
the patient should be considered excluded from the study and intention to treat
analysis.
Note: The use of a secondary closure device in the same leg is prohibited
during this study. A note to this effect should be entered into the patient*s
medical records.
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 |
|---|---|
| Other | CIV-23-06-04319 |
| CCMO | NL84689.000.23 |