Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
NCT ID: NCT05482555
Last Updated: 2023-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
171 participants
OBSERVATIONAL
2017-01-31
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention/treatment Surgical cut-down and arterial puncture under direct vision
Surgical cut-down and arterial puncture under direct vision.
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).
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).
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Karolinska University Hospital
OTHER
Responsible Party
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Magnus Dalén
MD, PhD
Locations
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Department of Cardiothoracic Surgery, Karolinska University Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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MANTA-ATAAD
Identifier Type: -
Identifier Source: org_study_id
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