| Eligibility |
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 22F sheath
(arteriotomy up to 26F).
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 <
100,000/µl or subjects on long term anticoagulants with an INR > 2 within 12 hours
prior to index procedure,
3. Significant anaemia (example: haemoglobin < 9 g/dL or haematocrit < 27%), within 24
hours prior to index procedure,
4. Known type II heparin-induced thrombocytopenia,
5. Documented left ventricular ejection fraction < 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 > 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 > 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 > 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:* If any Procedural Exclusion Criteria listed below are
met, then closure with PerQseal Elite device is not permitted,
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 > one needle puncture during the
primary procedure, with a needle larger than a micropuncture needle (> 21 gauge or >
0.819 mm diameter). (Note: not an exclusion if micropuncture technique under
ultrasound guidance used for femoral artery access [Ref. 19, 20]),
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) > 300 seconds immediately prior to sheath removal or if
ACT measurements are expected to be > 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 > 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 > 180 mmHg or diastolic blood
pressure > 110 mmHg) at the time of planned vascular closure,
38. Systolic blood pressure < 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.
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