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Enrolling by Invitation

NCT Number: NCT05912608

Optimal Strategy for Repair of Type A Acute Aortic Dissection

Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.

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Key information

Conditions

Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Diseases Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Francesco Nappi

Saint-Denis, 93200, France

About this study

The target population enrolled in the registry includes patients with TAAAD.The high volume of patients that will be enrolled in this registry will receive proximal and distal aortic repair in elective, urgent or emergency clinical condition. Efforts of investigators will be concentrated in TAAAD repair using a conservative approach of root preservation and hemiarch reconstruction in the majority of patients who will be referred in critical clinical condition. High-risk patients with older age or more comorbidities had more conservative repairs to limit surgical insult to these complicated patients. Total arch reconstruction and root replacement will be optional procedures for specific subgroups of patients who may benefit from a more complex index finger operation without incurring additional immediate risk.

Investigators hope to demonstrate a reduction in operative mortality and an improvement in early and late outcomes. The experience of investigators will be summarized in an algorithm for TAAAD repair with an analysis of early morbidity and mortality, as well as late survival and no reoperation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TAAD or intramural hematoma involving the ascending aorta
  • Patients aged > 18 years
  • Symptoms started within 7 days from surgery
  • Primary surgical repair of acute TAAD
  • Any other major cardiac surgical procedure concomitant with surgery for TAAD.

Exclusion criteria

  • Patients aged < 18 years
  • Onset of symptoms > 7 days from surgery
  • Prior procedure for TAAD
  • Concomitant endocarditis;
  • TAAD secondary to blunt or penetrating chest trauma.

Treatment and study plan

Conservative TAAAD-R

Procedure

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.

Other names: Ascending aortic root sparing replacement with or without hemiarch repair

Extensive TAAAD-R

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 hemiarch) or reimplantation of the innominate trunk only (partial hemiarch).

Other names: Aortic root procedures.TARP procedures

Primary outcomes

  1. Operative Mortality (OM)

    Time frame: 30-day

    Patients who died within 30 days

  2. Rate of Transient Neurologic Deficit (TND)

    Time frame: 30-day

    Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation

  3. Rate of permanent Neurologic Deficit (PND)

    Time frame: 30-day

    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.

Secondary outcomes

  1. Rate of perioperative Myocardial Infarction (MI)

    Time frame: 30-day

    Number of participants with MI based on fourth universal definition.

  2. Rate of spinal Cord Injury (SCI)

    Time frame: 30-day

    Number of participants with SCI intended as rate of paraplegia and/or paraparesis

  3. Rate of composite of Major Adverse Events (MAE)

    Time frame: 30-day

    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)

  4. Rate of composite of Major Adverse Pulmonary Events (MAPE)

    Time frame: 30-day

    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)

  5. Rate of reintervention

    Time frame: 10 years

    The number of participants who will require reoperation for the aortic valve, proximal aorta, or distal aorta.

  6. Late survival

    Time frame: 10 years

    The secondary endpoint of the study is the evaluation of late survival

Sponsors and collaborators

Lead sponsor

Centre Cardiologique du Nord

Other

Collaborators

  • Henri Mondor University Hospital
  • Ospedale San Camillo, Rome, Italy
  • Pitié-Salpêtrière Hospital
  • Universita degli Studi di Genova

Registry information

Official study title

Searching Optimal Tailored Strategy for Repair of Acute Type A Acute Aortic Dissection

Acronym: TARAD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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