NCT04831073

Brief 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. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,902

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
8 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.9 years until next milestone

Study Start

First participant enrolled

February 28, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

1.8 years

First QC Date

March 29, 2021

Last Update Submit

December 6, 2024

Conditions

Type A Aortic Dissection

Keywords

Aortic dissection

Outcome Measures

Primary Outcomes (2)

  • Mortality rate

    All-cause mortality

    During the index hospital stay until last follow-up control

  • 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

    During the index hospital stay until last follow-up control

Secondary Outcomes (8)

  • Incidence of stroke

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

  • Incidence of acute kidney injury

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

  • Incidence of surgical site infection

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

  • Incidence of reoperation for bleeding

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

  • Incidence and amount of blood transfusion

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

  • +3 more secondary outcomes

Study Arms (1)

Acute type A aortic dissection

Patients who underwent surgery for acute type A aortic dissection

Procedure: Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch

Interventions

Surgery on the ascending aorta with or without repair of the aortic root and/or aortic archPROCEDURE

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

Acute type A aortic dissection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

AZ St-Jan

Bruges, Belgium

Location

Saint-Luc's Hospital

Brussels, Belgium

Location

University Hospital Antwerp

Edegem, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

University Hospitals Leuven

Leuven, Belgium

Location

Institute of Clinical and Experimental Medicine

Prague, Czechia

Location

Helsinki University Hospital

Helsinki, Finland

Location

Henri Mondor University Hospital

Créteil, Paris, France

Location

University Hospital Jean Minjoz

Besançon, France

Location

University Heart & Vascular Centre Hamburg

Hamburg, Germany

Location

Leipzig Heart Center

Leipzig, Germany

Location

Münster University Hospital

Münster, Germany

Location

University of Torino

Torino, Italy

Location

University of Udine

Udine, Italy

Location

University of Verona Medical School

Verona, Italy

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

University Hospitals of Leicester

Leicester, United Kingdom

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

Southampton University Hospital

Southampton, United Kingdom

Location

Related Publications (13)

  • 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.

    PMID: 40569847DERIVED

  • 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.

    PMID: 40081929DERIVED

  • 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.

    PMID: 40071739DERIVED

  • 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.

    PMID: 39840731DERIVED

  • 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.

    PMID: 38768283DERIVED

  • 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.

    PMID: 38686961DERIVED

  • 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.

    PMID: 38458584DERIVED

  • 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.

    PMID: 38458387DERIVED

  • 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.

    PMID: 38288052DERIVED

  • 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.

    PMID: 37432422DERIVED

  • 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.

    PMID: 36912033DERIVED

  • 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.

    PMID: 36826589DERIVED

  • 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.

    PMID: 34112230DERIVED

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Study Officials

  • Fausto Biancari

    Helsinki University Hospital, Helsinki, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 5, 2021

Study Start

February 28, 2023

Primary Completion

December 6, 2024

Study Completion

December 6, 2024

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(5)CZ(1)GB(4)FR(2)DE(3)ES(1)IT(3)FI(1)