Hybrid vs. Conventional Surgery for Type A Aortic Dissection

Not Applicable

Completed

• Conditions: Acute Stanford Type A Aortic Dissection

• Registration Number: NCT07107711
• Lead Sponsor: The First Hospital of Hebei Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-03-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of the Composite Endpoint of 30-day Mortality, Stroke, and Acute Kidney Injury (Stage 2 or 3)	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 Outcome Measures

Name	Time	Method
All-Cause Mortality at 30 Days	Within 30 days post-procedure	The percentage of patients who died from any cause.
Incidence of Postoperative Stroke	Within 30 days post-procedure	The percentage of patients with a new focal neurological deficit lasting \>24 hours, confirmed by imaging.
Incidence of Stage ≥2 Acute Kidney Injury (AKI)	Within 30 days post-procedure	The percentage of patients developing AKI Stage 2 or 3, as defined by KDIGO criteria.
Operative Metrics	Intraoperative	Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours.
Duration of Mechanical Ventilation	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.
Incidence of Other Major Postoperative Complications	During hospital stay (up to 30 days post-procedure)	Includes pulmonary infection, severe hypoxemia, postoperative delirium (assessed via CAM-ICU), and reoperation for bleeding.
Change in Aortic Morphology Score	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).
Change in Quality of Life	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).
Incidence of Endoleak	1 Month Post-procedure, 3 Months Post-procedure	Presence of any endoleak detected on follow-up MRI.
Incidence of Cardiovascular Events	Through study completion (3 months)	Number of patients experiencing major adverse cardiovascular events (e.g., myocardial infarction, repeat aortic intervention) during follow-up.
Length of Intensive Care Unit (ICU) Stay	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.
Total Postoperative Hospital Stay	During the postoperative hospital stay (up to 30 days post-procedure)	The total number of days from surgery until hospital discharge.

Trial Locations

Locations (1)

The Fourth Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China