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

NCT05482555 | Completed

• 1 other identifier: MANTA-ATAAD
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• Femoral access site complication

  Seroma, wound infection, or nerve injury

  During the first 8 weeks after surgery

Secondary Outcomes (1)

• Femoral artery complication

  During the first 3 years after surgery

Study Arms (2)

Intervention/treatment Surgical cut-down and arterial puncture under direct vision

Surgical cut-down and arterial puncture under direct vision.

Procedure: 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).

Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

Interventions

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).

Percutaneous arteriotomy closed with closure device

Surgical cut-down and arterial puncture under direct vision PROCEDURE

Surgical cut-down and arterial puncture under direct vision.

Intervention/treatment Surgical cut-down and arterial puncture under direct vision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patientes operated for acute type A aortic dissection with femoral arterial cannulation between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of either surgical cut-down and arterial puncture under direct vision or percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device.

You may qualify if:

• Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Department of Cardiothoracic Surgery, Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 1, 2022
• Study Start: January 1, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)