PerQseal® Impella Early Feasibility Study (NCT04818541) | Clinical Trial Compass
CompletedNot Applicable
PerQseal® Impella Early Feasibility Study
United States19 participantsStarted 2021-06-29
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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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.
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),