Percutaneous Large Hole Vascular Closure Clinical Trial
Official title:
Early Feasibility Study of the Vivasure PerQseal® Closure Device System After Use of the Impella Device for Cardiogenic Shock or Protected Percutaneous Coronary Intervention
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05163548 -
PerQseal®+ Early Feasibility Study
|
N/A | |
| Recruiting |
NCT05653336 -
PerQseal® Clinical Study
|
N/A |