Outcomes of Aortic Dissection Repair

NCT05927090 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2026-05-19

No results posted yet for this study

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. 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.

Conditions

  • Type A Aortic Dissection
  • Ascending Aortic Dissection
  • Aortic Diseases
  • Aortic Arch
  • Aortic Valve Insufficiency
  • Aortic Root Dissection
  • Aortic Root Dilatation
  • Type B Aortic Dissection

Interventions

PROCEDURE

Conservative Root- Sparing Aortic Valve Resuspension with or without Hemiarch 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.

PROCEDURE

Extensive Ascending Aorta Replacement (AAR) with Aortic Root Replacement (ARR)

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

PROCEDURE

Extensive Ascending Aorta Replacement (AAR) with Total Arch Replacement (TARP)

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

Extensive Root and Ascending Aorta Replacement with Total Arch Replacement

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

PROCEDURE

Thoracic Endovascular Aortic Repair

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.

PROCEDURE

Open Thoracic Aortic Descendig Repair

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.

Sponsors & Collaborators

  • Henri Mondor University Hospital

    collaborator OTHER
  • Universita degli Studi di Genova

    collaborator OTHER
  • Pitié-Salpêtrière Hospital

    collaborator OTHER
  • Ospedale San Camillo, Rome, Italy

    collaborator UNKNOWN
  • Campus Bio-Medico University

    collaborator OTHER
  • Centre Cardiologique du Nord

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-01
Primary Completion
2021-12-30
Completion
2026-12-31

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 NCT05927090 on ClinicalTrials.gov