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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05482555
Recruitment Status : Completed
First Posted : August 1, 2022
Last Update Posted : January 4, 2023
Sponsor:
Information provided by (Responsible Party):
Magnus Dalén, Karolinska University Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Aortic Dissection Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device Procedure: Surgical cut-down and arterial puncture under direct vision

Study Design
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Study Type : Observational
Actual Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2022
Actual Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Intervention/treatment Surgical cut-down and arterial puncture under direct vision
Surgical cut-down and arterial puncture under direct vision.
 Procedure: Surgical cut-down and arterial puncture under direct vision
Surgical cut-down and arterial puncture under direct vision.
Percutaneous arteriotomy closed with closure device
Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Femoral access site complication [ Time Frame: During the first 8 weeks after surgery ]
    Seroma, wound infection, or nerve injury


Secondary Outcome Measures :
  1. Femoral artery complication [ Time Frame: During the first 3 years after surgery ]
    Pseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patientes operated for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.
Criteria

Inclusion Criteria:

  • Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.

Exclusion Criteria:

  • Non-femoral arterial cannulation
  • Concomitant femoro-femoral bypass
  • Conversion to ECMO with arterial inflow in the previously cannulated femoral artery
  • Death within 30 days from procedure
  • Loss to follow-up
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05482555


Locations
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Sweden
Department of Cardiothoracic Surgery, Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
More Information
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Responsible Party: Magnus Dalén, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT05482555    
Other Study ID Numbers: MANTA-ATAAD
First Posted: August 1, 2022    Key Record Dates
Last Update Posted: January 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data not planned to be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Dissection
Dissection, Blood Vessel
Aneurysm
Vascular Diseases
 Cardiovascular Diseases
Acute Aortic Syndrome
Aortic Diseases