PerQseal® Impella Early Feasibility Study

This study is a prospective, multi-center, single arm EFS. Patients undergoing use of an Impella device for cardiogenic shock or PPCI, requiring an arteriotomy created by 13 to 14 F sheaths (arteriotomies up to approx. 18 F), via the common femoral artery will be screened against the study inclusion/exclusion criteria. If the patient meets study eligibility requirements, they shall be invited to participate, provide informed consent, and shall subsequently be assigned a study ID number. Enrollment will occur at the point where the PerQseal study device first enters the patient's body.

The planned enrollment is a minimum of 20 treated patients at a maximum of 5 study sites located in the United States.

Inclusion criteria

• Age ≥ 19 years,
• Use of an Impella CP or 2.5 Impella device via the common femoral artery for protected percutaneous coronary intervention (PPCI) or cardiogenic shock,
• Duration of Impella use > 8 hours and ≤ 4 days if used for cardiogenic shock
• Duration of Impella use ≤ 6 hours if used for PPCI.
• Impella access sheath between 13 and 14 F,
• Potential subject or authorized representative willing and able to provide appropriate study-specific informed consent,
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.

Baseline Exclusion Criteria:

• Evidence of systemic bacterial or cutaneous infection, including groin infection,
• 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,
• Significant anemia (hemoglobin <9 g/dL or hematocrit < 27%), within 24 hours prior to index procedure,
• Known type II heparin-induced thrombocytopenia,
• Unilateral or bilateral lower extremity amputation.
• 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,
• Known existing nerve damage in the target leg,
• Known allergy to any of the materials used in the PerQseal® device (refer to Instructions for Use),
• Subject unsuitable for surgical repair of the target leg access site,
• Subject has undergone a percutaneous procedure greater than 8 F sheath in the target leg, within the 90 days prior to index procedure,
• 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,
• Prior evidence of anterior calcification within 10 mm proximal or distal to arteriotomy site,
• Target femoral artery diameter is less than 6 mm in diameter,
• Subject is enrolled in another investigational medical device or drug study which has not completed the required primary endpoint follow-up,
• Subject has been previously enrolled in this clinical study.
• 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:

• Initial common femoral arterial access achieved with manual palpation or blind arterial stick access, without use of an image guided approach (ultrasound or angiography).
• 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,
• 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)
• 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,
• 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,
• 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,
• Target puncture site is in a vascular graft,
• 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,
• Target arteriotomy located above the inferior epigastric artery and/or above the inguinal ligament based on bony landmarks,
• Subjects with an acute hematoma > 4 cm diameter, arteriovenous fistula, pseudoaneurysm, or intraluminal thrombosis at the target access site,
• Evidence of bleeding around the Impella sheath (BARC type 2 or higher),
• Angiographic evidence of arterial laceration, dissection or stenosis within the femoral artery that would preclude use of the PerQseal® device,
• Uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) just prior to planned vascular closure.