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Type A Aortic DissectionERTAADNCT04831073

European Registry of Type A Aortic Dissection

An observational study of Type A Aortic Dissection, run by Helsinki University Central Hospital at 20 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type A Aortic Dissection
What is being tested?
Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch
Type of treatment
Surgery or procedure
How many people
3,902 participants
Where
20 sitesin 8 countries
Study dates
28 Feb 2023to 6 Dec 2024
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who underwent surgical repair for acute type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta.

Who may be able to join

  • Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta;
  • Patients aged > 18 years:
  • Symptoms started within 7 days from surgery;
  • Primary surgical repair of acute type A aortic dissection;
  • Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection.

Who cannot join

  • Patients aged < 18 years;
  • Onset of symptoms > 7 days from surgery;
  • Prior procedure for type A aortic dissection;
  • Retrograde type A aortic dissection (with primary tear located in the descending aorta);
  • Concomitant endocarditis;
  • Type A aortic dissection secondary to blunt or penetrating chest trauma.

Trial locations and contacts

20 sites in 8 countries.

20 sites in 8 countries

Belgium5 sites

  • AZ St-Jan

    Bruges

  • Saint-Luc's Hospital

    Brussels

  • University Hospital Antwerp

    Edegem

  • Ziekenhuis Oost-Limburg

    Genk

  • University Hospitals Leuven

    Leuven

Other trials in Belgium

United Kingdom4 sites

  • University Hospitals of Leicester

    Leicester

  • Liverpool Heart and Chest Hospital

    Liverpool

  • Northern General Hospital

    Sheffield

  • Southampton University Hospital

    Southampton

Other trials in United Kingdom

Germany3 sites

  • University Heart & Vascular Centre Hamburg

    Hamburg

  • Leipzig Heart Center

    Leipzig

  • Münster University Hospital

    Münster

Other trials in Germany

Italy3 sites

  • University of Torino

    Torino

  • University of Udine

    Udine

  • University of Verona Medical School

    Verona

Other trials in Italy

France2 sites

  • University Hospital Jean Minjoz

    Besançon

  • Henri Mondor University Hospital

    Créteil, Paris

Other trials in France

Czechia1 site

  • Institute of Clinical and Experimental Medicine

    Prague

Other trials in Czechia

Finland1 site

  • Helsinki University Hospital

    Helsinki

Other trials in Finland

Spain1 site

  • Hospital Clínic de Barcelona

    Barcelona

Other trials in Spain

About this study

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

Read the detailed description

Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit.

Being tested
Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch
Keywords
Aortic dissection
Medical subject headings
Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery on the ascending aorta with or without repair of the aortic root and/or aortic archProcedure or surgery

    Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch

Study groups in NCT04831073
Study groupRoleWhat they receive
Acute type A aortic dissectionPatients who underwent surgery for acute type A aortic dissection
Receives: Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality rate

    All-cause mortality

    Measured: During the index hospital stay until last follow-up control

  2. Cumulative incidence of reoperation on the aorta

    Any surgical and endovascular procedure on any segment of the aorta for aortic dissection or its related complication

    Measured: During the index hospital stay until last follow-up control

Secondary outcomes (8)

  1. Incidence of stroke

    change in the level of consciousness, hemiplegia, hemiparesis, numbness, or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopia, amaurosis fugax, or other neurological signs or symptoms consistent with stroke duration of a focal or global neurological deficit ≥ 24 h; OR <24 h if available neuroimaging documents a new brain hemorrhage or infarct; OR the neurological deficit results in death.

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  2. Incidence of acute kidney injury

    It will be defined according to postoperative change in serum creatinine levels and its severity will be stratified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  3. Incidence of surgical site infection

    Proven infection involving deep sternal wound tissues and/or mediastinum.

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  4. Incidence of reoperation for bleeding

    Chest reopening for excessive bleeding.

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  5. Incidence and amount of blood transfusion

    Transfusions of red blood cells

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  6. Length of stay in the intensive care unit

    Duration of stay in the intensive care unit

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  7. Incidence of global brain ischemia

    Diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

  8. Incidence of paraplegia/paraparesis

    Bilateral weakness and/or multimodality sensory disturbance below the level of the ischemic spinal lesion.

    Measured: From date of procedure until the date of hospital discharge, assessed up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2021
  2. Study start28 Feb 2023
  3. Primary completion6 Dec 2024
  4. Study completion6 Dec 2024

Resources

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
Retrospective
Enrolment
3,902 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04831073
Sponsor's protocol ID
100968
Acronym
ERTAAD
Status last verified
Dec 2024
First submitted
29 Mar 2021
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Demal TJ, Knochenhauer T, Weimann J, Juvonen T, Makikallio T, Fiore A, Perrotti A, Pettinari M, Peterss S, Buech J, Radner C, Dell'Aquila AM, Wisniewski K, Pol M, Kacer P, Onorati F, Francica A, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Lega JR, Pinto AG, Acharya M, Field M, Kuduvalli M, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, D'Errigo P, Mariscalco G, El-Dean Z, Detter C, Reichenspurner H, Polvani G, Biancari F, Conradi L. Outcome after day- and nighttime surgery for acute type A aortic dissection. Eur J Cardiothorac Surg. 2025 Jun 3;67(6):ezaf192. doi: 10.1093/ejcts/ezaf192.

    PubMed 40569847

  • Biancari F, Makikallio T, Rosato S, Juvonen T, Mariscalco G, El-Dean Z, Acharya M, Pettinari M, Rodriguez-Lega J, Pinto AG, Perrotti A, Onorati F, Wisniewski K, Conradi L, Demal T, Pol M, Rocek J, Kacer P, Gatti G, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Peterss S, Buech J, Radner C, Field M, Harky A, Fiore A, Senemaud J, Mustonen C, Dell'Aquila AM, D'Errigo P, Polvani G, Di Perna D. Carotid artery dissection and neurological complications after surgery for type 1 aortic dissection. Open Heart. 2025 Mar 12;12(1):e002882. doi: 10.1136/openhrt-2024-002882.

    PubMed 40081929

  • Biancari F, Fileccia D, Ferrante L, Makikallio T, Juvonen T, Jormalainen M, Mariscalco G, El-Dean Z, Pettinari M, Rodriguez Lega J, Pinto AG, Perrotti A, Onorati F, Wisniewski K, Demal T, Kacer P, Rocek J, Di Perna D, Vendramin I, Piani D, Rinaldi M, Quintana E, Pruna-Guillen R, Peterss S, Buech J, Radner C, Kuduvalli M, Harky A, Fiore A, D'Alonzo M, Dell'Aquila AM, Gatti G, Conradi L, Ballotta A, Field M. Extent of surgical repair and outcomes after surgery for type A aortic dissection. BJS Open. 2025 Mar 4;9(2):zraf003. doi: 10.1093/bjsopen/zraf003.

    PubMed 40071739

  • Biancari F, Gatti G, Makikallio T, Juvonen T, Mariscalco G, El-Dean Z, Pettinari M, Rodriguez Lega J, Perrotti A, Onorati F, Wisniewki K, Demal T, Kacer P, Perna DD, Vendramin I, Rinaldi M, Ferrante L, Quintana E, Buech J, Radner C, Fiore A, Dell'Aquila AM, D'Errigo P, Rosato S, Polvani G, Peterss S. Ascending aortic replacement versus aortic root replacement in patients with type A aortic dissection involving the aortic root. Ther Adv Cardiovasc Dis. 2025 Jan-Dec;19:17539447241303408. doi: 10.1177/17539447241303408.

    PubMed 39840731

  • Dell'Aquila AM, Wisniewski K, Georgevici AI, Szabo G, Onorati F, Rossetti C, Conradi L, Demal T, Rukosujew A, Peterss S, Caroline R, Buech J, Fiore A, Folliguet T, Perrotti A, Herve A, Nappi F, Pinto AG, Lega JR, Pol M, Kacer P, Mazzaro E, Gatti G, Vendramin I, Piani D, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Acharya M, Sherzad H, Mariscalco G, Field M, Harky A, Kuduvalli M, Pettinari M, Rosato S, Juvonen T, Mikko J, Makikallio T, Mustonen C, Biancari F. Malperfusion syndrome in patients undergoing repair for acute type A aortic dissection: Presentation, mortality, and utility of the Penn classification. J Thorac Cardiovasc Surg. 2025 Sep;170(3):687-697. doi: 10.1016/j.jtcvs.2024.11.003. Epub 2024 Nov 9.

    PubMed 39522713

  • Biancari F, Lega JR, Mariscalco G, Peterss S, Buech J, Fiore A, Perrotti A, Rukosujew A, Pinto AG, Demal T, Wisniewski K, Pol M, Gatti G, Vendramin I, Rinaldi M, Pruna-Guillen R, Di Perna D, El-Dean Z, Sherzad H, Nappi F, Field M, Pettinari M, Jormalainen M, Dell'Aquila AM, Onorati F, Quintana E, Juvonen T, Makikallio T. Aortic arch surgery for DeBakey type 1 aortic dissection in patients aged 60 years or younger. BJS Open. 2024 May 8;8(3):zrae047. doi: 10.1093/bjsopen/zrae047.

    PubMed 38768283

  • Juvonen T, Vendramin I, Mariscalco G, Jormalainen M, Perrotti A, Herve A, Mazzaro E, Gatti G, Pettinari M, Peterss S, Buech J, Nappi F, Pinto AG, Rodriguez Lega J, Pol M, Rocek J, Kacer P, Rukosujew A, Wisniewski K, Piani D, Demal T, Conradi L, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Fiore A, Folliguet T, Acharya M, El-Dean Z, Field M, Kuduvalli M, Onorati F, Francica A, Makikallio T, Dell'Aquila AM, Mustonen C, Raivio P, Rosato S, Biancari F. Femoral arterial cannulation for surgical repair of stanford type A aortic dissection. World J Surg. 2024 Jul;48(7):1771-1782. doi: 10.1002/wjs.12203. Epub 2024 Apr 30.

    PubMed 38686961

  • Biancari F, Onorati F, Peterss S, Buech J, Mariscalco G, Lega JR, Pinto AG, Fiore A, Perrotti A, Herve A, Rukosujew A, Demal T, Conradi L, Wisniewski K, Pol M, Kacer P, Gatti G, Mazzaro E, Vendramin I, Piani D, Rinaldi M, Ferrante L, Pruna-Guillen R, Di Perna D, Gerelli S, El-Dean Z, Nappi F, Field M, Kuduvalli M, Pettinari M, Francica A, Jormalainen M, Dell'Aquila AM, Makikallio T, Juvonen T, Quintana E. Nature of Neurological Complications and Outcome After Surgery for Type A Aortic Dissection. Am J Cardiol. 2024 May 15;219:85-91. doi: 10.1016/j.amjcard.2024.03.001. Epub 2024 Mar 6.

    PubMed 38458584

  • Biancari F, Perrotti A, Juvonen T, Mariscalco G, Pettinari M, Lega JR, Di Perna D, Makikallio T, Onorati F, Wisniewki K, Demal T, Pol M, Gatti G, Vendramin I, Rinaldi M, Quintana E, Peterss S, Field M, Fiore A. Diameter and dissection of the abdominal aorta and the risk of distal aortic reoperation after surgery for type A aortic dissection. Int J Cardiol. 2024 Jun 1;404:131938. doi: 10.1016/j.ijcard.2024.131938. Epub 2024 Mar 7.

    PubMed 38458387

  • Biancari F, Demal T, Nappi F, Onorati F, Francica A, Peterss S, Buech J, Fiore A, Folliguet T, Perrotti A, Herve A, Conradi L, Rukosujew A, Pinto AG, Lega JR, Pol M, Rocek J, Kacer P, Wisniewski K, Mazzaro E, Vendramin I, Piani D, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Acharya M, Mariscalco G, Field M, Kuduvalli M, Pettinari M, Rosato S, D'Errigo P, Jormalainen M, Mustonen C, Makikallio T, Dell'Aquila AM, Juvonen T, Gatti G. Baseline risk factors of in-hospital mortality after surgery for acute type A aortic dissection: an ERTAAD study. Front Cardiovasc Med. 2024 Jan 15;10:1307935. doi: 10.3389/fcvm.2023.1307935. eCollection 2023.

    PubMed 38288052

  • Juvonen T, Jormalainen M, Mustonen C, Demal T, Fiore A, Perrotti A, Herve A, Mazzaro E, Gatti G, Pettinari M, Peterss S, Buech J, Nappi F, Conradi L, Pinto AG, Rodriguez Lega J, Pol M, Kacer P, Dell'Aquila AM, Rukosujew A, Wisniewski K, Vendramin I, Piani D, Ferrante L, Rinaldi M, Quintana E, Pruna-Guillen R, Gerelli S, Di Perna D, Folliguet T, Acharya M, Field M, Kuduvalli M, Onorati F, Rossetti C, Makikallio T, Raivio P, Mariscalco G, Biancari F. Direct Aortic Versus Supra-Aortic Arterial Cannulation During Surgery for Acute Type A Aortic Dissection. World J Surg. 2023 Nov;47(11):2899-2908. doi: 10.1007/s00268-023-07116-z. Epub 2023 Jul 11.

    PubMed 37432422

  • Biancari F, Juvonen T, Fiore A, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Dell'Aquila AM, Wisniewski K, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Rodriguez Lega J, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Nappi F, Gerelli S, Di Perna D, Gatti G, Mazzaro E, Rosato S, Raivio P, Jormalainen M, Mariscalco G. Current Outcome after Surgery for Type A Aortic Dissection. Ann Surg. 2023 Oct 1;278(4):e885-e892. doi: 10.1097/SLA.0000000000005840. Epub 2023 Mar 13.

    PubMed 36912033

  • Biancari F, Dell'Aquila AM, Gatti G, Perrotti A, Herve A, Touma J, Pettinari M, Peterss S, Buech J, Wisniewski K, Juvonen T, Jormalainen M, Mustonen C, Rukosujew A, Demal T, Conradi L, Pol M, Kacer P, Onorati F, Rossetti C, Vendramin I, Piani D, Rinaldi M, Ferrante L, Quintana E, Pruna-Guillen R, Lega JR, Pinto AG, Acharya M, El-Dean Z, Field M, Harky A, Kuduvalli M, Nappi F, Gerelli S, Di Perna D, Mazzaro E, Rosato S, Fiore A, Mariscalco G. Interinstitutional analysis of the outcome after surgery for type A aortic dissection. Eur J Trauma Emerg Surg. 2023 Aug;49(4):1791-1801. doi: 10.1007/s00068-023-02248-2. Epub 2023 Feb 24.

    PubMed 36826589

  • Biancari F, Mariscalco G, Yusuff H, Tsang G, Luthra S, Onorati F, Francica A, Rossetti C, Perrotti A, Chocron S, Fiore A, Folliguet T, Pettinari M, Dell'Aquila AM, Demal T, Conradi L, Detter C, Pol M, Ivak P, Schlosser F, Forlani S, Chetty G, Harky A, Kuduvalli M, Field M, Vendramin I, Livi U, Rinaldi M, Ferrante L, Etz C, Noack T, Mastrobuoni S, De Kerchove L, Jormalainen M, Laga S, Meuris B, Schepens M, El Dean Z, Vento A, Raivio P, Borger M, Juvonen T. European registry of type A aortic dissection (ERTAAD) - rationale, design and definition criteria. J Cardiothorac Surg. 2021 Jun 10;16(1):171. doi: 10.1186/s13019-021-01536-5.

    PubMed 34112230

Questions about this trial

What is this clinical trial studying?

An observational study of Type A Aortic Dissection, run by Helsinki University Central Hospital at 20 sites in 8 countries.

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 5 inclusion and 6 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Belgium, United Kingdom, Germany, Italy, France and 3 more countries. 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?

Mortality rate (time frame: During the index hospital stay until last follow-up control). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831073, which also lists 14 linked publications.

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 11 Dec 2024.

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