An observational study in Aortic Dissection, Aortic Arch and Aortic Dissection Rupture, sponsored by Centre Cardiologique du Nord. Enrolling by invitation at 1 site in France. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Centre Cardiologique du Nord · Observational
Among 18 studies in Aortic Dissection with a site in France — 5 open to participants now, 8 under way, none of them phase 3. Aortic Dissection · France.
Among the 18 studies in Aortic Dissection with a site in France, this one is the 3rd largest by planned enrollment of the 12 observational ones, is the only one that started in 2014, is one of 12 observational ones, and was the 16th registered.
205 studies on the registry are indexed under Aortic Dissection; 73 are open to participants now.
This study's planned enrollment of 900 is above the median of 230 across 115 observational studies indexed under Aortic Dissection.
Browse Aortic Dissection studies →5 of the 18 studies in Aortic Dissection with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 44 Aortic Dissection studies recruiting now, 27 (61%) set no upper age limit and 5 (11%) stop at 75 or younger; 9 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · healthy volunteers too.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 1 started in 2014.
Median enrollment 51 across the 6 interventional studies, 280 across the 12 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
5 of 18 have an industry lead sponsor. The 10 most frequent:
Centre Cardiologique du Nord is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
Centre Cardiologique du Nord has 2 studies filed under Aortic Dissection — fewer than ten, so there is no comparison to draw.
2 of the studies in Aortic Dissection with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03707743IRCCS San RaffaeleRegistry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE) | 2026-11-30 |
| NCT05896397Cook Research IncorporatedEuropean Aortic Data Collection Project | 2027-01 |
Among the 18 studies in Aortic Dissection with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD
Substantial evidence has suggested a decrease of early mortality during the last years, however recently the Nordic Consortium for Acute Type A Aortic Dissection registry recorded 18% of 30-day mortality after surgery for ATAAD. Similarly, the prospective German Registry for Acute Aortic Dissection Type A confirmed this data reporting a 30-day mortality of 16.9%. Again, results from recent analysis of the Society of Thoracic Surgeon database that report 7353 procedures from 2014 and 2017 for acute TAAD revealed a 30-day mortality of 17%. Understanding the balance between the patient's conditions which may not allow extensive procedure and those treatment strategies which may limit the risk of late adverse events in patients who remain alive long after the surgery is essential for an appropriate management of ATAAD. The best treatment option in patients with ATAAD is dictated by the balance between patient conditions that may not allow for extensive procedures and those more conservative treatment strategies that limit the risk of late adverse events in patients who remain alive long after surgery. surgery. However, previous evidence from large series of patients do not provide information on the long-term durability of these procedures.
Here investigators planned a multicenter study to evaluate the contemporary early outcomes and duration of different surgical strategies for 15-year acute ATAAD in a large study population.
The retrospective multicenter study including patients who underwent surgery for acute TAAAD at 5 centers of cardiac surgery located in 2 European countries and Japan (2 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected fron patients (conservative vs estensive TAAD- R) treated during the study period and 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. Data on consecutive patients with acute TAAD will be collected with pre-specified baseline, operative and outcome variables.
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:
The Conservative procedure will include patients receiving ascending aortic root sparing replacement with or without the implantation of the aortic hemiarch
Procedure: Conservative TAAD-R
The extensive procedure will include patients receiving ascending aorta replacement associated to TARP
Procedure: Extensive TAAD- R
Cardiac arrest will be ensured using antegrade potassium-rich cardioplegia solution delivered directly into the coronary ostium or after coronary sinus cannula insertion, in patients with aortic regurgitation aorta will be resected down to the sinotubular junction and the thrombus located in the false lumen of the aortic root will be removed so that the aortic lesion could be visualized. The commissures will be resuspended using 4-0 or 5-0 sutures reinforced with a Teflon pledget over each 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 revealing normal-sized aortic roots associated with poor-quality valve leaflets, concomitant aortic valve replacement with conventional xenograft or mechanical prosthesis will be preferred.
Also known as: Ascending Aortic Root Sparing Replacement with or without Hemiarch Repair
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 undergoing replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure.Total arch replacement procedures (TARP) will fulfilled 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: Aortic root procedures.TARP procedures. Frozen Elephant Trunk (FET) procedure
Operative Mortality (OM)
Patients who died within 30 days
Time frame: 30-day
Rate of acute heart failure
Number of participants with postoperative heart failure 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
Stroke
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 global brain ischemia
Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.
Time frame: 30-days
Rate of mesenteric ischemia
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Time frame: 30-days
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-days
Rate of paraplegia/paraparesis
Rate of bilateral weakness and/or multimodality sensory disturb- ance below the level of the ischemic spinal lesion.
Time frame: 30-day
Rate of perioperative bleeding
Number of participants will receive postoprative 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
Rate of 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
Late outcomes
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-days
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-days
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-days
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-days
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-days
Plan to share: No
Ran from Jan 2014 to primary completion in Apr 2025, 135 months.
Of 48 observational studies under Aortic Dissection, half reached primary completion within 83 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 135. This study's 135 months is above that.
How these figures are worked out, and which studies are left out of them.
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Centre Cardiologique du Nord