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

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.

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Key information

Conditions

Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiothoracic Surgery, Karolinska University Hospital

Stockholm, Sweden

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Procedure

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

Procedure

Surgical cut-down and arterial puncture under direct vision.

Primary outcomes

Femoral access site complication

Time frame: During the first 8 weeks after surgery

Seroma, wound infection, or nerve injury

Secondary outcomes

Femoral artery complication

Time frame: During the first 3 years after surgery

Pseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Aug 1, 2022
Registry last updated: Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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