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NCT Number: NCT07107711

Hybrid vs. Conventional Surgery for Type A Aortic Dissection

This is a prospective, randomized controlled trial designed to compare the clinical efficacy and short-term outcomes of one-stop hybrid surgery versus conventional total arch replacement with frozen elephant trunk (FET) in patients with acute Stanford Type A Aortic Dissection. The study evaluates differences in perioperative metrics, postoperative complications, 30-day survival, aortic remodeling, and quality of life.

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Key information

Conditions

Acute Stanford Type A Aortic Dissection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

About this study

Stanford Type A Aortic Dissection (TAAD) is a life-threatening condition requiring urgent surgical repair. This study tests the hypothesis that a one-stop hybrid surgery protocol is superior to conventional repair. 140 patients with acute TAAD were randomized to one of two groups. The experimental group received a one-stop hybrid surgery, which combines open total arch replacement using a standard branched surgical graft with the antegrade deployment of a separate stent graft, performed under moderate hypothermia. The active comparator group underwent conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis, performed under deep hypothermic circulatory arrest. The study's main objective is to compare key clinical outcomes between the two surgical strategies, including a primary composite endpoint of 30-day mortality, stroke, and acute kidney injury, to provide evidence on the optimal surgical approach for this high-risk population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-70 years.
  • Diagnosis of acute TAAD (symptom onset <72 hours) confirmed by imaging, with dissection involving the aortic arch requiring total arch replacement.
  • Relative hemodynamic stability, defined as a systolic blood pressure >90 mmHg without high-dose vasopressor support (norepinephrine >0.1 µg/kg/min).
  • Provision of informed consent.

Exclusion criteria

  • Age >70 years.
  • Stanford type B or non-dissection pathologies.
  • Life-threatening comorbidities prohibitive of major cardiac surgery (e.g., advanced multiorgan failure from other causes, active malignancy).
  • Absolute contraindications to surgery.
  • History of previous ascending aorta or aortic arch surgery.
  • Inability to provide informed consent.

Treatment and study plan

One-Stop Hybrid Surgery

Procedure

With the patient under moderate hypothermia (approx. 28°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using a standard 4-branched graft. After the open repair is complete, a separate, distinct covered stent graft is deployed antegradely into the descending aorta through the open distal end of the arch graft. Completion angiography confirms correct placement.

Conventional Total Arch Replacement with Frozen Elephant Trunk

Procedure

With the patient under deep hypothermic circulatory arrest (23°C-25°C) and cardiopulmonary bypass, surgeons perform a total arch replacement using an integrated hybrid prosthesis (Frozen Elephant Trunk), which consists of a vascular graft sutured to a covered stent graft. This single device is deployed antegradely into the descending aorta, and the arch vessels are then reattached to the branches of the prosthetic graft.

Primary outcomes

  1. Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)

    Time frame: Within 30 days post-procedure

    A composite outcome measure including all-cause mortality, any new focal neurological deficit lasting >24 hours and confirmed by imaging (stroke), and acute kidney injury defined as Stage 2 or 3 by KDIGO criteria. The measure is the percentage of patients in each group who experience at least one of these events.

Secondary outcomes

  1. All-Cause Mortality at 30 Days

    Time frame: Within 30 days post-procedure

    The percentage of patients who died from any cause.

  2. Incidence of Postoperative Stroke

    Time frame: Within 30 days post-procedure

    The percentage of patients with a new focal neurological deficit lasting >24 hours, confirmed by imaging.

  3. Incidence of Stage ≥2 Acute Kidney Injury (AKI)

    Time frame: Within 30 days post-procedure

    The percentage of patients developing AKI Stage 2 or 3, as defined by KDIGO criteria.

  4. Operative Metrics

    Time frame: Intraoperative

    Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours.

  5. Duration of Mechanical Ventilation

    Time frame: During the postoperative hospital stay (up to 30 days post-procedure)

    The total time a patient requires mechanical ventilation support after surgery, measured in hours.

  6. Incidence of Other Major Postoperative Complications

    Time frame: During hospital stay (up to 30 days post-procedure)

    Includes pulmonary infection, severe hypoxemia, postoperative delirium (assessed via CAM-ICU), and reoperation for bleeding.

  7. Change in Aortic Morphology Score

    Time frame: 1 Month Post-procedure, 3 Months Post-procedure

    Aortic remodeling assessed by a 7-parameter scoring system on Magnetic Resonance Imaging (MRI). The score ranges from 0 to 16, with lower scores indicating more favorable remodeling (a better outcome).

  8. Change in Quality of Life

    Time frame: 3 Months Post-procedure

    Assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) summary score. The score ranges from 0 to 100, where higher scores indicate better quality of life (a better outcome).

  9. Incidence of Endoleak

    Time frame: 1 Month Post-procedure, 3 Months Post-procedure

    Presence of any endoleak detected on follow-up MRI.

  10. Incidence of Cardiovascular Events

    Time frame: Through study completion (3 months)

    Number of patients experiencing major adverse cardiovascular events (e.g., myocardial infarction, repeat aortic intervention) during follow-up.

  11. Length of Intensive Care Unit (ICU) Stay

    Time frame: During the postoperative hospital stay (up to 30 days post-procedure)

    The total number of days a patient stays in the Intensive Care Unit (ICU) following surgery.

  12. Total Postoperative Hospital Stay

    Time frame: During the postoperative hospital stay (up to 30 days post-procedure)

    The total number of days from surgery until hospital discharge.

Sponsors and collaborators

Lead sponsor

The First Hospital of Hebei Medical University

Other

Registry information

Official study title

One-Stop Hybrid Versus Conventional Surgery for Acute Type A Aortic Dissection: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

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.