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

NCT05482555 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 171

Last updated 2023-01-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Karolinska University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05482555 on ClinicalTrials.gov