Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
- Conditions
- Aortic Dissection
- Registration Number
- NCT05482555
- Lead Sponsor
- Karolinska University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
- Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Femoral access site complication During the first 8 weeks after surgery Seroma, wound infection, or nerve injury
- Secondary Outcome Measures
Name Time Method Femoral artery complication During the first 3 years after surgery Pseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure
Trial Locations
- Locations (1)
Department of Cardiothoracic Surgery, Karolinska University Hospital
🇸🇪Stockholm, Sweden
Department of Cardiothoracic Surgery, Karolinska University Hospital🇸🇪Stockholm, Sweden