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Enrolling by Invitation

NCT Number: NCT05927090

Outcomes of Aortic Dissection Repair

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.

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Key information

Conditions

Type A Aortic Dissection Acute Aortic Syndrome Aneurysm Aortic Arch Aortic Diseases Aortic Dissection Aortic Root Dilatation Aortic Root Dissection Aortic Valve Disease Aortic Valve Insufficiency Ascending Aortic Dissection Cardiovascular Diseases Dissection, Ascending Aorta Dissection, Blood Vessel Dissection, Thoracic Aorta Heart Diseases Heart Valve Diseases Type B Aortic Dissection Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Francesco Nappi

Saint-Denis, 93200, France

About this study

For patients requiring surgical repair for a TAAD, there is still some disagreement regarding which factors should be considered during the preoperative evaluation, the best decision-making process to undertake that best assesses procedural risk, and how operative mortality can be predicted. Furthermore, the impact of different surgical strategies on outcomes remains unclear.This prospective study was designed to evaluate the impact of the center volume-outcome relationship and that on mortality which remain poorly understood. A better understanding of the determinants of outcome in patients undergoing surgery could support decision making, aid in the design of service delivery, and improve outcomes for surviving patients who are referred to specialized centers for treatment of aortic disease.Furthermore, the study aims to evaluate whether precise risk stratification can provide better patient counseling and be used for unit-surgeon benchmarking. Ultimately in the present study, we aimed to investigate outcome predictors in patients undergoing surgery for TAAD, including clinical and perioperative variables as well as to evaluate follow up beyond 15 years.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged > 18 years
  • TAAD or intramural hematoma involving the ascending aorta
  • 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 Root- Sparing Aortic Valve Resuspension with or without Hemiarch Repair

Procedure

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.

Other names: Ascending Aorta Replacement with Aortic Valve Replacement (AVR)

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

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 receive replacement of the aortic root using a biologic or mechanical composite valve graft or valve-sparing root reimplantation procedure associated to AAR

Other names: ARR with or without aortic valve sparing

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

Procedure

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)

Other names: AAR with TARP or Frozen Elephant Trunk (FET)

Extensive Root and Ascending Aorta Replacement with Total Arch Replacement

Procedure

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

Other names: Full anterior thoracic aorta replacement with partial hemiarch repair or TARP or FET

thoracic endovascular aortic repair

Procedure

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.

Other names: TEVAR

Open Thoracic Aortic Descendig Repair

Procedure

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.

Other names: TOAR

Primary outcomes

  1. Operative Mortality (OM)

    Time frame: 30-day

    Patients who died within 30 days

  2. Rate of mesenteric ischemia

    Time frame: 30-day

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

  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.

  4. 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)

  5. Rate of perioperative Myocardial Infarction (MI)

    Time frame: 30-day

    Number of participants with MI based on fourth universal definition.

  6. Rate of acute heart failure (AHF)

    Time frame: 30-day and in-hospital mortality

    Number of participants with postoperative AHF 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.

Secondary outcomes

  1. 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

  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 acute kidney injury

    Time frame: 30-day

    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.

  4. Rate of perioperative bleeding

    Time frame: 30-day

    Number of participants who will receive postoperative 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

  5. Reoperation for bleeding

    Time frame: 30-day

    Number of participants who will receive postoperative chest reopening for excessive bleeding.

  6. Rate of mechanical circulatory support

    Time frame: 30-day

    Number of participants who will receive the use of intra-aortic balloon pump and/or venoarterial extracorporeal membrane oxygenation for postoperative acute heart failure.

  7. 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)

  8. Rate of reintervention

    Time frame: 18-years

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

  9. Rate of late survival

    Time frame: 18-years

    Data on patient's survival status will be collected

Other outcomes

  1. Rate of urgent procedure

    Time frame: 30-day

    Number of participants who will require scheduled procedure within 24 hours of admission.

  2. Rate of emergency grade 1

    Time frame: 30-day

    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.

  3. Rate of emergency grade 2

    Time frame: 30-day

    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.

  4. Rate of salvage grade 1

    Time frame: 30-day

    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.

  5. Rate of salvage grade 2

    Time frame: 30-day

    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.

Sponsors and collaborators

Lead sponsor

Centre Cardiologique du Nord

Other

Collaborators

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

Registry information

Official study title

Surgical Strategy for Repair of Aortic Dissection: A Multicenter Registry

Acronym: STAAD

Important dates

Study start
2005
Primary completion
2021
Study completion
2026
First posted
Jul 3, 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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