An interventional study of One-Stop Hybrid Surgery and Conventional Total Arch Replacement with Frozen Elephant Trunk in Acute Stanford Type A Aortic Dissection, sponsored by The First Hospital of Hebei Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by The First Hospital of Hebei Medical University · Not applicable, Interventional, and Treatment
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.
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.
The First Hospital of Hebei Medical University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Patients were randomized to undergo one-stop hybrid surgery, which included total aortic arch replacement with a standard 4-branched artificial vascular graft combined with antegrade stent grafting of the proximal descending aorta, performed in a single stage under moderate hypothermia (approx. 28°C).
Procedure: One-Stop Hybrid Surgery
Patients were randomized to undergo conventional total arch replacement using an integrated frozen elephant trunk (FET) hybrid prosthesis. The procedure was performed under deep hypothermic circulatory arrest (target temperature 23°C-25°C).
Procedure: Conventional Total Arch Replacement with Frozen Elephant Trunk
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.
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.
Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)
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.
Time frame: Within 30 days post-procedure
All-Cause Mortality at 30 Days
The percentage of patients who died from any cause.
Time frame: Within 30 days post-procedure
Incidence of Postoperative Stroke
The percentage of patients with a new focal neurological deficit lasting \>24 hours, confirmed by imaging.
Time frame: Within 30 days post-procedure
Incidence of Stage ≥2 Acute Kidney Injury (AKI)
The percentage of patients developing AKI Stage 2 or 3, as defined by KDIGO criteria.
Time frame: Within 30 days post-procedure
Operative Metrics
Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours.
Time frame: Intraoperative
Duration of Mechanical Ventilation
The total time a patient requires mechanical ventilation support after surgery, measured in hours.
Time frame: During the postoperative hospital stay (up to 30 days post-procedure)
Incidence of Other Major Postoperative Complications
Includes pulmonary infection, severe hypoxemia, postoperative delirium (assessed via CAM-ICU), and reoperation for bleeding.
Time frame: During hospital stay (up to 30 days post-procedure)
Change in Aortic Morphology Score
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).
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Change in Quality of Life
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).
Time frame: 3 Months Post-procedure
Incidence of Endoleak
Presence of any endoleak detected on follow-up MRI.
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Incidence of Cardiovascular Events
Number of patients experiencing major adverse cardiovascular events (e.g., myocardial infarction, repeat aortic intervention) during follow-up.
Time frame: Through study completion (3 months)
Length of Intensive Care Unit (ICU) Stay
The total number of days a patient stays in the Intensive Care Unit (ICU) following surgery.
Time frame: During the postoperative hospital stay (up to 30 days post-procedure)
Total Postoperative Hospital Stay
The total number of days from surgery until hospital discharge.
Time frame: During the postoperative hospital stay (up to 30 days post-procedure)
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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