| Eligibility |
Inclusion Criteria:
1. Age = 19 years,
2. Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected
percutaneous coronary intervention (PPCI) or cardiogenic shock,
3. Duration of Impella use > 8 hours and = 4 days if used for cardiogenic shock
4. Duration of Impella use = 6 hours if used for PPCI.
5. Impella access sheath between 13 and 14 F,
6. Potential subject or authorized representative willing and able to provide appropriate
study-specific informed consent,
7. Females who are not pregnant or lactating and not planning to become pregnant for the
duration of the study.
Baseline Exclusion Criteria:
1. Evidence of 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 anemia (hemoglobin <9 g/dL or hematocrit < 27%), within 24 hours prior to
index procedure,
4. Known type II heparin-induced thrombocytopenia,
5. Unilateral or bilateral lower extremity amputation.
6. Rest pain (e.g., Rutherford category 4 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,
7. Known existing nerve damage in the target leg,
8. Known allergy to any of the materials used in the PerQseal® device (refer to
Instructions for Use),
9. Subject unsuitable for surgical repair of the target leg access site,
10. Subject has undergone a percutaneous procedure greater than 8 F sheath in the target
leg, within the 90 days prior to index procedure,
11. Subject has undergone a percutaneous procedure of 8 F sheath or less using an
absorbable or suture mediated closure device for hemostasis, in the target vessel,
within the 90 days prior to index procedure,
12. Prior evidence of anterior calcification within 10 mm proximal or distal to
arteriotomy site,
13. Target femoral artery diameter is less than 6 mm in diameter,
14. Subject is enrolled in another investigational medical device or drug study which has
not completed the required primary endpoint follow-up,
15. Subject has been previously enrolled in this clinical study.
16. Current COVID-19 infection (with or without symptoms), recent positive test for
COVID-19, or recent exposure to a person with COVID-19 infection.
Procedural Exclusion Criteria:
1. Initial common femoral arterial access achieved with manual palpation or blind
arterial stick access, without use of an image guided approach (ultrasound or
angiography).
2. Difficult dilation during initial target femoral artery access (e.g., that damages or
kinks sheath dilators) while step-dilating up to the large-bore device,
3. During arterial puncture, the target femoral artery suspected to have experienced a
back arterial wall needle puncture or underwent > one needle puncture during the
primary procedure,with a needle larger than a Micropuncture needle (18 gauge)
4. 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,
5. Significant blood loss/transfusion (defined as requiring transfusion of 4 or more
units of blood products) during primary procedure or within 30 days prior to index
procedure,
6. 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,
7. Target puncture site is in a vascular graft,
8. Target arteriotomy in the profunda femoris or superficial femoral artery or is in
common femoral artery, but within 10 mm proximal of the bifurcation of the superficial
femoral/ profunda femoris artery,
9. Target arteriotomy located above the inferior epigastric artery and/or above the
inguinal ligament based on bony landmarks,
10. Subjects with an acute hematoma > 4 cm diameter, arteriovenous fistula,
pseudoaneurysm, or intraluminal thrombosis at the target access site,
11. Evidence of bleeding around the Impella sheath (BARC type 2 or higher),
12. Angiographic evidence of arterial laceration, dissection or stenosis within the
femoral artery that would preclude use of the PerQseal® device,
13. Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood
pressure > 110 mmHg) just prior to planned vascular closure.
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