Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection

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
• Healthy volunteers accepted
• Adult, Older adult

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.

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: Early Complication and Outcomes in Surgical vs no Surgical Involvement of Aortic Arch in Type A Aortic Dissection

Conditions

Aortic Dissection, Aortic Arch, Aortic Dissection Rupture, Aortic Dilatation

Being tested

Conservative TAAD-R, Extensive TAAD- R

Keywords

Type A Aortic Dissection (TAAAD), Root-Sparing Replacement, Ascending Aorta Replacement, Partial Arch Repair, Total Arch Replacement (TARP), Frozen Elephant Trunk (FET), Hemiarch Procedures

Medical subject headings

Aortic Dissection

What participants receive

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

• Conservative TAAD-RProcedure or surgery

  Also called Ascending Aortic Root Sparing Replacement with or without Hemiarch Repair

  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.

• Extensive TAAD- RProcedure or surgery

  Also called Aortic root procedures.TARP procedures. Frozen Elephant Trunk (FET) procedure

  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)

What is being measured

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

1. Operative Mortality (OM)

   Patients who died within 30 days

   Measured: 30-day

2. 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.

   Measured: 30-day

3. 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.

   Measured: 30-day

4. Rate of global brain ischemia

   Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.

   Measured: 30-days

5. Rate of mesenteric ischemia

   Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea

   Measured: 30-days

6. 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-days

Timeline

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

1. First posted22 Jun 2023
2. Study start1 Jan 2014
3. Primary completion30 Apr 2025
4. Study completion30 Dec 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (5)Papers the sponsor has linked to this study.
• Other trials for 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.