An observational study in Type A Aortic Dissection, Ascending Aortic Dissection and Aortic Diseases, sponsored by Centre Cardiologique du Nord. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Centre Cardiologique du Nord · Observational
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.
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 .
108 studies on the registry are indexed under Aortic Diseases; 43 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 186 across 62 observational studies indexed under Aortic Diseases.
Browse Aortic Diseases studies →Centre Cardiologique du Nord is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Procedure: Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair
Patient who will require the extensive procedure including ascending aorta replacement associated to root replacement with or without sparing of the aortic valve
Procedure: Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)
Patient who will require the extensive procedure including ascending aorta replacement associated to TARP
Procedure: Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)
Patient who will require the extensive procedure including root and ascending aorta replacement associated to TARP
Procedure: Extensive Root and Ascending Aorta Replacement with Total Arch Replacement
Patient who will require the procedure including thoracic endovascular aorta repair
Procedure: Thoracic Endovascular Aortic Repair
Patient who will require the procedure including open thoracic aorta repair
Procedure: Open Thoracic Aortic Descendig Repair
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.
Also known as: Ascending Aorta Replacement with Aortic Valve Replacement (AVR)
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
Also known as: ARR with or without aortic valve sparing
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)
Also known as: AAR with TARP or Frozen Elephant Trunk (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
Also known as: Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FET
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.
Also known as: TEVAR
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.
Also known as: TOAR
Operative Mortality (OM)
Patients who died within 30 days
Time frame: 30-day
Rate of mesenteric ischemia
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Time frame: 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.
Time frame: 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)
Time frame: 30-day
Rate of perioperative Myocardial Infarction (MI)
Number of participants with MI based on fourth universal definition.
Time frame: 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.
Time frame: 30-day and in-hospital mortality
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
Time frame: 30-day
Rate of spinal Cord Injury (SCI)
Number of participants with SCI intended as rate of paraplegia and/or paraparesis
Time frame: 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.
Time frame: 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
Time frame: 30-day
Reoperation for bleeding
Number of participants who will receive postoperative chest reopening for excessive bleeding.
Time frame: 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.
Time frame: 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)
Time frame: 30-day
Rate of reintervention
The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.
Time frame: 18-years
Rate of late survival
Data on patient's survival status will be collected
Time frame: 18-years
Rate of urgent procedure
Number of participants who will require scheduled procedure within 24 hours of admission.
Time frame: 30-day
Rate of emergency grade 1
Number of participants will require procedure within 24 hours of hospital admission and who are symptomatic or minimally symptomatic with stable hemodynamic conditions and no signs of malperfusion.
Time frame: 30-day
Rate of emergency grade 2
Number of participants who will require procedure within the first 6 hours of hospital admission due to hemodynamic instability despite use of concentration inotropes and/or malperfusion.
Time frame: 30-day
Rate of salvage grade 1
Number of participants who will require immediate surgical procedure. Rate of cardio pulmonary resuscitation with external chest compressions and/or open cardiac massage between induction of anesthesia and initiation of cardiopulmonary bypass.
Time frame: 30-day
Rate of salvage grade 2
Number of participants who will require immediate surgical procedure. Rate of cardiopulmonary resuscitation with external chest compressions en route to the operating theatre or prior to induction of anesthesia.
Time frame: 30-day
Ran from Jan 2005 to primary completion in Dec 2021, 203 months.
Of 33 observational studies under Aortic Diseases, half reached primary completion within 98 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 203. This study's 203 months is above that.
How these figures are worked out, and which studies are left out of them.
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