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NCT05482555 Clinical Trial

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

Aortic Dissection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05482555
Other study ID # MANTA-ATAAD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date June 2022

Study information
Verified date January 2023
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 171
Est. completion date June 2022
Est. primary completion date June 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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).
• Surgical cut-down and arterial puncture under direct vision
Surgical cut-down and arterial puncture under direct vision.

Locations
Country Name City State
Sweden Department of Cardiothoracic Surgery, Karolinska University Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Femoral access site complication Seroma, wound infection, or nerve injury During the first 8 weeks after surgery
Secondary Femoral artery complication Pseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure During the first 3 years after surgery
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