Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Hybrid Group (n=70) | Experimental | 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). |
|
| Active Comparator: Conventional Group (n=70) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality at 30 Days | The percentage of patients who died from any cause. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei | 050000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| 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. | Within 30 days post-procedure |
| Operative Metrics | Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours. | Intraoperative |
| Duration of Mechanical Ventilation | The total time a patient requires mechanical ventilation support after surgery, measured in hours. | 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. | 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). | 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). | 3 Months Post-procedure |
| Incidence of Endoleak | Presence of any endoleak detected on follow-up MRI. | 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. | 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. | 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. | During the postoperative hospital stay (up to 30 days post-procedure) |