Type A Aortic DissectionSTAADNCT05927090
Outcomes of Aortic Dissection Repair
An observational study of Type A Aortic Dissection and Ascending Aortic Dissection, run by Centre Cardiologique du Nord at 1 site in France.
Trial summary
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases
- What is being tested?
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) and Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
- Type of treatment
- Surgery or procedure
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2005to 31 Dec 2026
- How long will I take part?
- 18 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The STAAD study is a prospective multicenter registry including patients who will underwent surgery for acute TAAD at 6 centers of cardiac surgery located in 2 European countries and Japan (3 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected from patients (conservative vs estensive Type A aortic dissection repair) who will be treated during the study period. In addition, the aim will be to gather further data for future clinical research on this topic. Preoperative and postoperative variables will be included during in-hospital stay and follow-up data instead they will be included on subsequent encounters for all other patients who will be hospitalized.
Who may be able to join
- Patients aged > 18 years
- TAAD or intramural hematoma involving the ascending aorta
- Symptoms started within 7 days from surgery
- Primary surgical repair of acute TAAD
- Any other major cardiac surgical procedure concomitant with surgery for TAAD.
Who cannot join
- Patients aged < 18 years
- Onset of symptoms > 7 days from surgery
- Prior procedure for TAAD
- Concomitant endocarditis;
- TAAD secondary to blunt or penetrating chest trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Surgical Strategy for Repair of Aortic Dissection: A Multicenter Registry
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients.
In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)The main approach to acute type B non-complicated aortic dissection (TBAD) has always been to use medicines to control the patient's heart rate and blood pressure. However, recent findings suggest that a large number of patients treated for acute complicated (TBAAD) and non-complicated TBAD experience aortic complications, such as aneurysmal degeneration, at a later stage.
Read the detailed description
For patients requiring surgical repair for a TAAD, there is still some disagreement regarding which factors should be considered during the preoperative evaluation, the best decision-making process to undertake that best assesses procedural risk, and how operative mortality can be predicted. Furthermore, the impact of different surgical strategies on outcomes remains unclear.This prospective study was designed to evaluate the impact of the center volume-outcome relationship and that on mortality which remain poorly understood. A better understanding of the determinants of outcome in patients undergoing surgery could support decision making, aid in the design of service delivery, and improve outcomes for surviving patients who are referred to specialized centers for treatment of aortic disease.Furthermore, the study aims to evaluate whether precise risk stratification can provide better patient counseling and be used for unit-surgeon benchmarking. Ultimately in the present study, we aimed to investigate outcome predictors in patients undergoing surgery for TAAD, including clinical and perioperative variables as well as to evaluate follow up beyond 15 years.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch, Aortic Valve Insufficiency, Aortic Root Dissection
- Being tested
- Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair, Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR), Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP), Extensive Root and Ascending Aorta Replacement with Total Arch Replacement, Thoracic Endovascular Aortic Repair
- Keywords
- DeBakey type I Dissection, DeBakey type II Dissection, Type A Acute Aortic Dissection (TAAAD), Root-Sparing Replacement, Ascending Aorta Replacement, Partial Arch Repair, Hemiarch Procedures, Total Arch Replacement (TARP), Frozen Elephant Trunk (FET) Hemiarch Procedures, Type B Acute Aortic Dissection (TBAAD), Type B non acuteAortic Dissection (TBAD)
- Medical subject headings
- Dissection, Ascending Aorta, Aortic Diseases, Aortic Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch RepairProcedure or surgery
Also called Ascending Aorta Replacement with Aortic Valve Replacement (AVR)
Cardiac arrest will be performed by administering a potassium-rich antegrade cardioplegia solution delivered directly into the coronary ostium or in the case of aortic regurgitation after insertion of the coronary sinus cannula.The aorta will be resected up to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion can be visualized. The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget above every commissure. A 4-0 or 5-0 polypropylene suture will be chosen to seal the proximal anastomosis and this suture line will also be used to secure the intima to the adventitia. In patients demonstrating normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferable.
Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)Procedure or surgery
Also called ARR with or without aortic valve sparing
Patients who experienced dilatation of the sinuses of Valsalva > 4.5 cm in diameter on computed tomography imaging, those with connective tissue disease, or those in whom intimal tears extended into the sinuses, will receive replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure associated to AAR
Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)Procedure or surgery
Also called AAR with TARP or Frozen Elephant Trunk (FET)
Total arch replacement procedures (TARP) will performed with the use of deep hypothermic circulatory arrest and with either antegrade or retrograde cerebral perfusion, maintaining systemic cooling between 19°C to 25°C and depending on the surgeon's practice.TARPs will be carried out using 1- and 4-branch grafts and involved the resection of all the aortic tissue up to the left common carotid artery (total arch)
Extensive Root and Ascending Aorta Replacement with Total Arch ReplacementProcedure or surgery
Also called Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FET
This extensive procedure will include complete replacement of the anterior thoracic aorta extending to part or all of the aortic arch. It will be performed with the previously reported techniques
Thoracic Endovascular Aortic RepairProcedure or surgery
Also called TEVAR
TEVAR patients have a higher incidence of complications and reintervention than open repair patients. TEVAR complications may include endoleak, retrograde type A aortic dissection, stent-graft migration, fracture or collapse, and increased size.
Open Thoracic Aortic Descendig RepairProcedure or surgery
Also called TOAR
Surveillance imaging can detect complications of open repair, such as graft infection and anastomotic pseudoaneurysm. After open repair or TEVAR, patients may develop progressive aneurysmal dilatation of adjacent or remote aortic segments.
| Study group | Role | What they receive |
|---|---|---|
| Ascending Aorta Replacement (AAR) with or without Hemiarch Repair | Patients who will require a conservative prosthetic replacement of the ascending aorta with or without hemiarch.Patients who required a concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis Receives: Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair | |
| Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) | Patient who will require the extensive procedure including ascending aorta replacement associated to root replacement with or without sparing of the aortic valve Receives: Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) | |
| Ascending Aorta Replacement with Total Arch Replacement (TARP) | Patient who will require the extensive procedure including ascending aorta replacement associated to TARP Receives: Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP) | |
| Root and Ascending Aorta Replacement with Total Arch Replacement | Patient who will require the extensive procedure including root and ascending aorta replacement associated to TARP Receives: Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch Replacement | |
| Thoracic Endovascular Aortic Repair | Patient who will require the procedure including thoracic endovascular aorta repair Receives: Procedure: Thoracic Endovascular Aortic Repair | |
| Open Thoracic Aortic Repair | Patient who will require the procedure including open thoracic aorta repair Receives: Procedure: Open Thoracic Aortic Descendig Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Mortality (OM)
Patients who died within 30 days
Measured: 30-day
Rate of mesenteric ischemia
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Measured: 30-day
Rate of permanent Neurologic Deficit (PND)
Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours.
Measured: 30-day
Rate of composite of Major Adverse Events (MAE)
Number of participants with MAE which will include the composite rate of myocardial infarction, cerebrovascular accident, need for dialysis, or need for tracheostomy according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Measured: 30-day
Rate of perioperative Myocardial Infarction (MI)
Number of participants with MI based on fourth universal definition.
Measured: 30-day
Rate of acute heart failure (AHF)
Number of participants with postoperative AHF who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device.
Measured: 30-day and in-hospital mortality
Secondary outcomes (9)
Rate of Transient Neurologic Deficit (TND)
Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation
Measured: 30-day
Rate of spinal Cord Injury (SCI)
Number of participants with SCI intended as rate of paraplegia and/or paraparesis
Measured: 30-day
Rate of acute kidney injury
Number of participants with postoperative change in serum creatinine concentration. Severity will be stratified on the basis of number of participants with the KDIGO (Kney Disease Improving Global Outcomes) criteria.
Measured: 30-day
Rate of perioperative bleeding
Number of participants who will receive postoperative transfused red blood cell units. The E-CABG ( coronary artery by pass grafting) classification of bleeding rate has been proposed as a simple classification of perioperative bleeding
Measured: 30-day
Reoperation for bleeding
Number of participants who will receive postoperative chest reopening for excessive bleeding.
Measured: 30-day
Rate of mechanical circulatory support
Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure.
Measured: 30-day
Rate of composite of Major Adverse Pulmonary Events (MAPE)
Number of participants with MAPE which will include the composite rate of intubation >48 hours, pneumonia, reintubation, tracheostomy according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Measured: 30-day
Rate of reintervention
The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.
Measured: 18-years
Rate of late survival
Data on patient's survival status will be collected
Measured: 18-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2005
- Primary completion30 Dec 2021
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Type A Aortic DissectionStudies of the same condition, open and under way.
- 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
- 1,200 participants (estimated)
- Target duration
- 18 Years
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital, Universita degli Studi di Genova, Pitié-Salpêtrière Hospital, Ospedale San Camillo, Rome, Italy, Campus Bio-Medico University
- Responsible party
- Principal investigator, Francesco Nappi, Centre Cardiologique du Nord
- Investigators
- Francesco Nappi, MD, Study chair, Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927090
- Sponsor's protocol ID
- CN-202201173-3
- Other IDs
- CN-202201173-3
- Acronym
- STAAD
- Status last verified
- May 2026
- First submitted
- 3 Jun 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mahase E. Half of patients with acute aortic dissection in England die before reaching a specialist centre. BMJ. 2020 Jan 23;368:m304. doi: 10.1136/bmj.m304. No abstract available.
PubMed 31974270Braverman AC. Acute aortic dissection: clinician update. Circulation. 2010 Jul 13;122(2):184-8. doi: 10.1161/CIRCULATIONAHA.110.958975. No abstract available.
PubMed 20625143Howard DP, Banerjee A, Fairhead JF, Perkins J, Silver LE, Rothwell PM; Oxford Vascular Study. Population-based study of incidence and outcome of acute aortic dissection and premorbid risk factor control: 10-year results from the Oxford Vascular Study. Circulation. 2013 May 21;127(20):2031-7. doi: 10.1161/CIRCULATIONAHA.112.000483. Epub 2013 Apr 18.
PubMed 23599348Biancari 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 36912033Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aortic dissection: the UK National Adult Cardiac Surgical Audit. Eur Heart J. 2021 Dec 28;43(1):44-52. doi: 10.1093/eurheartj/ehab586.
PubMed 34468733Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2019 May;157(5):1750-1758. doi: 10.1016/j.jtcvs.2018.09.020. Epub 2018 Sep 29.
PubMed 30401530Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.
PubMed 36001309Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.
PubMed 26088302O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.04.144. Epub 2020 Jun 26.
PubMed 32599034
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Strategy for Repair of Aortic Dissection: A Multicenter Registry
- ClinicalTrials.gov ID
- NCT05927090
- Acronym / sponsor ID
- STAAD / CN-202201173-3
- Conditions
- Type A Aortic Dissection, Ascending Aortic Dissection, Aortic Diseases, Aortic Arch, Aortic Valve Insufficiency, Aortic Root Dissection
- Keywords
- DeBakey type I Dissection, DeBakey type II Dissection, Type A Acute Aortic Dissection (TAAAD), Root-Sparing Replacement, Ascending Aorta Replacement, Partial Arch Repair, Hemiarch Procedures, Total Arch Replacement (TARP)
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital, Universita degli Studi di Genova, Pitié-Salpêtrière Hospital, Ospedale San Camillo, Rome, Italy, Campus Bio-Medico University
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Jul 2023 (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.
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients.
In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)The main approach to acute type B non-complicated aortic dissection (TBAD) has always been to use medicines to control the patient's heart rate and blood pressure. However, recent findings suggest that a large number of patients treated for acute complicated (TBAAD) and non-complicated TBAD experience aortic complications, such as aneurysmal degeneration, at a later stage.
Detailed description
For patients requiring surgical repair for a TAAD, there is still some disagreement regarding which factors should be considered during the preoperative evaluation, the best decision-making process to undertake that best assesses procedural risk, and how operative mortality can be predicted. Furthermore, the impact of different surgical strategies on outcomes remains unclear.This prospective study was designed to evaluate the impact of the center volume-outcome relationship and that on mortality which remain poorly understood. A better understanding of the determinants of outcome in patients undergoing surgery could support decision making, aid in the design of service delivery, and improve outcomes for surviving patients who are referred to specialized centers for treatment of aortic disease.Furthermore, the study aims to evaluate whether precise risk stratification can provide better patient counseling and be used for unit-surgeon benchmarking. Ultimately in the present study, we aimed to investigate outcome predictors in patients undergoing surgery for TAAD, including clinical and perioperative variables as well as to evaluate follow up beyond 15 years.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ascending Aorta Replacement (AAR) with or without Hemiarch Repair | – | Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch RepairPatients who will require a conservative prosthetic replacement of the ascending aorta with or without hemiarch.Patients who required a concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis |
| Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) | – | Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)Patient who will require the extensive procedure including ascending aorta replacement associated to root replacement with or without sparing of the aortic valve |
| Ascending Aorta Replacement with Total Arch Replacement (TARP) | – | Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)Patient who will require the extensive procedure including ascending aorta replacement associated to TARP |
| Root and Ascending Aorta Replacement with Total Arch Replacement | – | Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch ReplacementPatient who will require the extensive procedure including root and ascending aorta replacement associated to TARP |
| Thoracic Endovascular Aortic Repair | – | Procedure: Thoracic Endovascular Aortic RepairPatient who will require the procedure including thoracic endovascular aorta repair |
| Open Thoracic Aortic Repair | – | Procedure: Open Thoracic Aortic Descendig RepairPatient who will require the procedure including open thoracic aorta repair |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The STAAD study is a prospective multicenter registry including patients who will underwent surgery for acute TAAD at 6 centers of cardiac surgery located in 2 European countries and Japan (3 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected from patients (conservative vs estensive Type A aortic dissection repair) who will be treated during the study period. In addition, the aim will be to gather further data for future clinical research on this topic. Preoperative and postoperative variables will be included during in-hospital stay and follow-up data instead they will be included on subsequent encounters for all other patients who will be hospitalized.
Key inclusion criteria (5 listed)
- Patients aged > 18 years
- TAAD or intramural hematoma involving the ascending aorta
- Symptoms started within 7 days from surgery
- Primary surgical repair of acute TAAD
- Any other major cardiac surgical procedure concomitant with surgery for TAAD.
Key exclusion criteria (5 listed)
- Patients aged < 18 years
- Onset of symptoms > 7 days from surgery
- Prior procedure for TAAD
- Concomitant endocarditis;
- TAAD secondary to blunt or penetrating chest trauma.
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 |
|---|---|---|
| Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch RepairAlso: Ascending Aorta Replacement with Aortic Valve Replacement (AVR)Cardiac arrest will be performed by administering a potassium-rich antegrade cardioplegia solution delivered directly into the coronary ostium or in the case of aortic regurgitation after insertion of the coronary sinus cannula.The aorta will be resected up to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion can be visualized. The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget above every commissure. A 4-0 or 5-0 polypropylene suture will be chosen to seal the proximal anastomosis and this suture line will also be used to secure the intima to the adventitia. In patients demonstrating normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferable. | Procedure or surgery | Ascending Aorta Replacement (AAR) with or without Hemiarch Repair |
| Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)Also: ARR with or without aortic valve sparingPatients who experienced dilatation of the sinuses of Valsalva > 4.5 cm in diameter on computed tomography imaging, those with connective tissue disease, or those in whom intimal tears extended into the sinuses, will receive replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure associated to AAR | Procedure or surgery | Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR) |
| Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)Also: AAR with TARP or Frozen Elephant Trunk (FET)Total arch replacement procedures (TARP) will performed with the use of deep hypothermic circulatory arrest and with either antegrade or retrograde cerebral perfusion, maintaining systemic cooling between 19°C to 25°C and depending on the surgeon's practice.TARPs will be carried out using 1- and 4-branch grafts and involved the resection of all the aortic tissue up to the left common carotid artery (total arch) | Procedure or surgery | Ascending Aorta Replacement with Total Arch Replacement (TARP) |
| Extensive Root and Ascending Aorta Replacement with Total Arch ReplacementAlso: Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FETThis extensive procedure will include complete replacement of the anterior thoracic aorta extending to part or all of the aortic arch. It will be performed with the previously reported techniques | Procedure or surgery | Root and Ascending Aorta Replacement with Total Arch Replacement |
| Thoracic Endovascular Aortic RepairAlso: TEVARTEVAR patients have a higher incidence of complications and reintervention than open repair patients. TEVAR complications may include endoleak, retrograde type A aortic dissection, stent-graft migration, fracture or collapse, and increased size. | Procedure or surgery | Thoracic Endovascular Aortic Repair |
| Open Thoracic Aortic Descendig RepairAlso: TOARSurveillance imaging can detect complications of open repair, such as graft infection and anastomotic pseudoaneurysm. After open repair or TEVAR, patients may develop progressive aneurysmal dilatation of adjacent or remote aortic segments. | Procedure or surgery | Open Thoracic Aortic Repair |
Primary outcome
Operative Mortality (OM)
Time frame: 30-day
Patients who died within 30 days
Rate of mesenteric ischemia
Time frame: 30-day
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Rate of permanent Neurologic Deficit (PND)
Time frame: 30-day
Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours.
Rate of composite of Major Adverse Events (MAE)
Time frame: 30-day
Number of participants with MAE which will include the composite rate of myocardial infarction, cerebrovascular accident, need for dialysis, or need for tracheostomy according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Rate of perioperative Myocardial Infarction (MI)
Time frame: 30-day
Number of participants with MI based on fourth universal definition.
Rate of acute heart failure (AHF)
Time frame: 30-day and in-hospital mortality
Number of participants with postoperative AHF who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device.
9 secondary outcomes
Rate of Transient Neurologic Deficit (TND)
Time frame: 30-day
Rate of spinal Cord Injury (SCI)
Time frame: 30-day
Rate of acute kidney injury
Time frame: 30-day
Rate of perioperative bleeding
Time frame: 30-day
Reoperation for bleeding
Time frame: 30-day
Rate of mechanical circulatory support
Time frame: 30-day
Rate of composite of Major Adverse Pulmonary Events (MAPE)
Time frame: 30-day
Rate of reintervention
Time frame: 18-years
Rate of late survival
Time frame: 18-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Results publication: PubMed 31974270Mahase E. Half of patients with acute aortic dissection in England die before reaching a specialist centre. BMJ. 2020 Jan 23;368:m304. doi: 10.1136/bmj.m304. No abstract available.
- Results publication: PubMed 20625143Braverman AC. Acute aortic dissection: clinician update. Circulation. 2010 Jul 13;122(2):184-8. doi: 10.1161/CIRCULATIONAHA.110.958975. No abstract available.
- Results publication: PubMed 23599348Howard DP, Banerjee A, Fairhead JF, Perkins J, Silver LE, Rothwell PM; Oxford Vascular Study. Population-based study of incidence and outcome of acute aortic dissection and premorbid risk factor control: 10-year results from the Oxford Vascular Study. Circulation. 2013 May 21;127(20):2031-7. doi: 10.1161/CIRCULATIONAHA.112.000483. Epub 2013 Apr 18.
- Results publication: PubMed 36912033Biancari 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.
- Results publication: PubMed 34468733Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aortic dissection: the UK National Adult Cardiac Surgical Audit. Eur Heart J. 2021 Dec 28;43(1):44-52. doi: 10.1093/eurheartj/ehab586.
- Results publication: PubMed 30401530Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2019 May;157(5):1750-1758. doi: 10.1016/j.jtcvs.2018.09.020. Epub 2018 Sep 29.
- Results publication: PubMed 36001309Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.
- Results publication: PubMed 26088302Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.
- Results publication: PubMed 32599034O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.04.144. Epub 2020 Jun 26.
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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.
Francesco Nappi, MD study chair
Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
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 Type A Aortic Dissection and Ascending Aortic Dissection, run by Centre Cardiologique du Nord at 1 site in France.
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 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: enrolling by invitation, as of the sponsor's last update on 19 May 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Operative Mortality (OM) (time frame: 30-day). The study lists 6 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 NCT05927090, which also lists 9 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 19 May 2026.