A Safety and Technical Feasibility Evaluation of the Arterica Closure Device for Large-Bore Vascular Closure Following Interventional Procedures

Arterica, Inc.0 sites4 target enrollmentJuly 28, 2020

Overview

Phase: N/A
Intervention: Not specified
Conditions: Not specified
Sponsor: Arterica, Inc.
Enrollment: 4
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

As a first-in-human study the study is a safety and technical evaluation. The primary safety endpoint was evaluated at 30 days post procedure and looked at major complications from the study device. The technical success endpoint was evaluated immediately post procedure and looked at the device ability to close the artery. There were 4 study participants enrolled, with a total of 7 procedures completed using the device, since 3 of the 4 subjects had 2 sites requiring closure. All participants were male, over the age of 70. For the technical feasibility endpoint, 6 of 7 procedures met the study definition of technical success. For the safety endpoint, there was 1 SAE related to the study device.

Registry

who.int

Start Date

July 28, 2020

End Date

May 19, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Arterica, Inc.

Eligibility Criteria

Inclusion Criteria

•Subject is \>18 years of age at time of consent
•Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the common femoral artery

Exclusion Criteria

•Subject is pregnant or lactating
•Subject has known bleeding disorder
•Subject has recent history of common femoral artery closure with any common femoral artery closure device or any open procedure in the target groin.
•Subject has recent history of common femoral artery closure with manual compression.
•Subject unable to ambulate.
•Subject has a unilateral or bilateral lower extremity amputation