PerQseal® Impella Early Feasibility Study

Completed · Not applicable

Conditions studied: Percutaneous Large Hole Vascular Closure

In brief

The purpose of this Clinical Investigation Plan is to assess the initial feasibility results of the PerQseal® device, when used on this very specific Impella population. Safety and effectiveness will be assessed in patients where an Impella device was used for either cardiogenic shock or PPCI. Closure of femoral arterial access sites created with 13 to 14 F sheaths will be studied, assessing the need for alternative therapy other than manual compression or adjunctive endovascular ballooning.

Key facts

Study ID

NCT04818541

Run by

Vivasure Medical Limited

People needed

19

Starts

2021-06-29

Expected to finish

2023-03-01

Last updated by the study team

2023-04-26

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

Where it is running

• The Valley Hospital — Ridgewood, New Jersey, United States
• University of Buffalo — Buffalo, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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