EFS PerQSeal Plus

Early Feasibility Study of the Vivasure PerQseal®+ (PerQseal® Plus) Vascular Closure Device when used to Achieve Hemostasis of Common Femoral Arteriotomies Created by 14 to 22 F Sheaths in Patients Undergoing Percutaneous Transcatheter Procedures

Objective

The objective of this Early Feasibility Study (EFS) is to evaluate the initial safety and preliminary effectiveness of the PerQseal®+ VCD in a small number of subjects when used to achieve hemostasis of common femoral arteriotomies created by 14 to 22 F sheaths arteriotomy up to 26 F) in subjects undergoing Percutaneous Transcatheter procedures.

Eligibility

Candidates for participation in the study must meet all the

following inclusion criteria:

  • Age ≥ 19 years,
  • Clinically indicated for a large bore interventional transcatheter procedure, e.g., transcatheter aortic valve repair (TAVR) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) using a percutaneous common femoral arteriotomy created by a 14 to 22 F sheath,
  • Subject is willing and able to provide appropriate study specific informed consent, follow protocol procedures, and comply with follow-up visit requirements,
  • Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study