PerQseal® Impella Early Feasibility Study

Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention

NCT04818541•Vivasure Medical Limited

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

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.

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,
+19 more criteria

Locations (4)

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

Key Dates

Start Date

June 29, 2021

Primary Completion Date

January 1, 2023

Completion Date

March 1, 2023

Last Updated

April 26, 2023

Enrollment

ACTUAL participants

Conditions

Percutaneous Large Hole Vascular Closure

Interventions

PPCI

DEVICE

Cardiogenic shock

DEVICE