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

NCT05912634 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2026-05-19

No results posted yet for this study

Summary

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

Conditions

  • Aortic Dissection
  • Aortic Arch
  • Aortic Dissection Rupture
  • Aortic Dilatation

Interventions

PROCEDURE

Conservative 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.

PROCEDURE

Extensive TAAD- R

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)

Sponsors & Collaborators

  • Henri Mondor University Hospital

    collaborator OTHER

  • Universita degli Studi di Genova

    collaborator OTHER

  • Pitié-Salpêtrière Hospital

    collaborator OTHER

  • Centre Cardiologique du Nord

    lead OTHER

Principal Investigators

  • Francesco Nappi · Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2025-04-30
Completion
2026-12-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05912634 on ClinicalTrials.gov