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

• ClinicalTrials.gov Identifier: NCT05482555
• Recruitment Status: Completed
• First Posted: August 1, 2022
• Last Update Posted: January 4, 2023
• Sponsor: Karolinska University Hospital
• Information provided by (Responsible Party): Magnus Dalén, Karolinska University Hospital

Tracking Information

• First Submitted Date: July 29, 2022
• First Posted Date: August 1, 2022
• Last Update Posted Date: January 4, 2023
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 1, 2023)

Femoral access site complication [ Time Frame: During the first 8 weeks after surgery ]

Seroma, wound infection, or nerve injury

Original Primary Outcome Measures (submitted: July 29, 2022)

Vascular groin-related complication [ Time Frame: During the first 8 weeks after surgery ]

Access site seroma, infection, claudication, or nerve injury

Current Secondary Outcome Measures (submitted: January 1, 2023)

Femoral artery complication [ Time Frame: During the first 3 years after surgery ]

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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
• Official Title: Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Aortic Dissection

Intervention

• Procedure: 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).
• Procedure: Surgical cut-down and arterial puncture under direct vision
  Surgical cut-down and arterial puncture under direct vision.

Study Groups/Cohorts

• Intervention/treatment Surgical cut-down and arterial puncture under direct vision
  Surgical cut-down and arterial puncture under direct vision.
  Intervention: 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).
  Intervention: Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 1, 2023): 171
• Original Estimated Enrollment (submitted: July 29, 2022): 200
• Actual Study Completion Date: June 2022
• Actual Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT05482555
• Other Study ID Numbers: MANTA-ATAAD
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Individual participant data not planned to be shared.

• Current Responsible Party: Magnus Dalén, Karolinska University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Karolinska University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Karolinska University Hospital
• Verification Date: January 2023