Aortic DissectionNCT05482555
Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
An observational study of Aortic Dissection, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Percutaneous arteriotomy closed using a plug-based arteriotomy closure device and Surgical cut-down and arterial puncture under direct vision
- Type of treatment
- Surgery or procedure
- How many people
- 171 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2017to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Cardiothoracic Surgery, Karolinska University Hospital
Stockholm
About this study
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
- Being tested
- Percutaneous arteriotomy closed using a plug-based arteriotomy closure device, Surgical cut-down and arterial puncture under direct vision
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous arteriotomy closed using a plug-based arteriotomy closure deviceProcedure or surgery
Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).
Surgical cut-down and arterial puncture under direct visionProcedure or surgery
Surgical cut-down and arterial puncture under direct vision.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment Surgical cut-down and arterial puncture under direct vision | Surgical cut-down and arterial puncture under direct vision. Receives: 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). Receives: Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral access site complication
Seroma, wound infection, or nerve injury
Measured: During the first 8 weeks after surgery
Secondary outcomes (1)
Femoral artery complication
Pseudoaneurysm, local dissection, stenosis, intermittent claudication, or vascular closure device failure
Measured: During the first 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study startJan 2017
- Primary completionJun 2022
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Dalén, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05482555
- Sponsor's protocol ID
- MANTA-ATAAD
- Status last verified
- Jan 2023
- First submitted
- 29 Jul 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data not planned to be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Plug-based Femoral Arteriotomy Closure Device Use in Surgery for Acute Type A Aortic Disection
- ClinicalTrials.gov ID
- NCT05482555
- Acronym / sponsor ID
- MANTA-ATAAD
- Conditions
- Aortic Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2022 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 1 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment Surgical cut-down and arterial puncture under direct vision | – | Procedure: Surgical cut-down and arterial puncture under direct visionSurgical cut-down and arterial puncture under direct vision. |
| Percutaneous arteriotomy closed with closure device | – | Procedure: Percutaneous arteriotomy closed using a plug-based arteriotomy closure devicePercutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Operated for acute type A aortic dissection between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous arteriotomy closed using a plug-based arteriotomy closure devicePercutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania). | Procedure or surgery | Percutaneous arteriotomy closed with closure device |
| Surgical cut-down and arterial puncture under direct visionSurgical cut-down and arterial puncture under direct vision. | Procedure or surgery | Intervention/treatment Surgical cut-down and arterial puncture under direct vision |
Primary outcome
Femoral access site complication
Time frame: During the first 8 weeks after surgery
Seroma, wound infection, or nerve injury
1 secondary outcome
Femoral artery complication
Time frame: During the first 3 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No. Individual participant data not planned to be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral access site complication (time frame: During the first 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.