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PerQseal® IDE Clinical Study – PATCH (NCT05653336)

PerQseal® Clinical Study

A Multicentre, Single-Arm, Pivotal Study to Evaluate the Safety and Efficacy of the Vivasure PerQseal® Closure Device System when used to Achieve Haemostasis of Common Femoral Arteriotomies Created by 12 to 22 F Sheaths in Patients Undergoing Percutaneous Catheter-Based Interventional Procedures

PI: Zvonimir Krajcer, MD

SPONSOR: Vivasure Medical, Ltd.

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Eligibility Requirements:

  1. Age ≥ 19 years
  2. Clinically indicated for an interventional endovascular procedure, e.g., transcatheter aortic valve repair (TAVR) or endovascular abdominal aortic aneurysm repair (EVAR), or thoracic endovascular aneurysm repair (TEVAR) using a common femoral arteriotomy created by a 12 to 22 F sheath