PerQseal®+ Early Feasibility Study

Percutaneous Large Hole Vascular Closure Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This study is a prospective, multi-center, single arm EFS. Patients undergoing a percutaneous trancatheter procedure, requiring an arteriotomy created by 14 - 22 F sheaths (arteriotomies up to approx. 26 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®+ VCD study device first enters the patient's body.

The planned enrollment is 15 treated patients at a maximum of 5 study sites (minimum of 3) located in the United States. ;

Related Conditions & MeSH terms

• Percutaneous Large Hole Vascular Closure

• NCT number: NCT05163548
• Study type: Interventional
• Source: Vivasure Medical Limited
• Status: Completed
• Phase: N/A
• Start date: March 8, 2022
• Completion date: July 7, 2022