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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05482555
Enrollment
171
Registered
2022-08-01
Start date
2017-01-31
Completion date
2022-06-30
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Dissection

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.

Interventions

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.

Sponsors

Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Femoral access site complicationDuring the first 8 weeks after surgerySeroma, wound infection, or nerve injury

Secondary

MeasureTime frameDescription
Femoral artery complicationDuring the first 3 years after surgeryPseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026