NCT05482555

Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 171 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

A single-center prospective study. Patients undergoing surgery for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed either with surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
PROCEDURE	Percutaneous arteriotomy closed using a plug-based arteriotomy closure device	Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).
PROCEDURE	Surgical cut-down and arterial puncture under direct vision	Surgical cut-down and arterial puncture under direct vision.

Timeline

• Start date: 2017-01-01
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2022-08-01
• Last updated: 2023-01-04

Locations

1 site across 1 country: Sweden