Acute Stanford Type A Aortic DissectionNCT07107711
Hybrid vs. Conventional Surgery for Type A Aortic Dissection
A study testing One-Stop Hybrid Surgery and Conventional Total Arch Replacement with Frozen Elephant Trunk in people with Acute Stanford Type A Aortic Dissection, run by The First Hospital of Hebei Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Stanford Type A Aortic Dissection
- What is being tested?
- One-Stop Hybrid Surgery and Conventional Total Arch Replacement with Frozen Elephant Trunk
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
About this study
Official title: One-Stop Hybrid Versus Conventional Surgery for Acute Type A Aortic Dissection: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Acute Stanford Type A Aortic Dissection
- Being tested
- One-Stop Hybrid Surgery, Conventional Total Arch Replacement with Frozen Elephant Trunk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-Stop Hybrid SurgeryProcedure or surgery
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 TrunkProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: One-Stop Hybrid Surgery |
| 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). Receives: Procedure: Conventional Total Arch Replacement with Frozen Elephant Trunk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days post-procedure
Secondary outcomes (12)
All-Cause Mortality at 30 Days
The percentage of patients who died from any cause.
Measured: 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.
Measured: 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.
Measured: Within 30 days post-procedure
Operative Metrics
Includes total operative time, cardiopulmonary bypass duration, and aortic cross-clamp duration. Measured in minutes or hours.
Measured: Intraoperative
Duration of Mechanical Ventilation
The total time a patient requires mechanical ventilation support after surgery, measured in hours.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 3 Months Post-procedure
Incidence of Endoleak
Presence of any endoleak detected on follow-up MRI.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the postoperative hospital stay (up to 30 days post-procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jan 2021
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Stanford Type A Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qi Hu, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107711
- Sponsor's protocol ID
- 2020139
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Stop Hybrid Versus Conventional Surgery for Acute Type A Aortic Dissection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07107711
- Acronym / sponsor ID
- 2020139
- Conditions
- Acute Stanford Type A Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Hybrid Group (n=70) | Experimental | Procedure: One-Stop Hybrid SurgeryPatients 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 | Procedure: Conventional Total Arch Replacement with Frozen Elephant TrunkPatients 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One-Stop Hybrid SurgeryWith 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. | Procedure or surgery | Experimental: Hybrid Group (n=70) |
| Conventional Total Arch Replacement with Frozen Elephant TrunkWith 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. | Procedure or surgery | Active Comparator: Conventional Group (n=70) |
Primary outcome
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.
12 secondary outcomes
All-Cause Mortality at 30 Days
Time frame: Within 30 days post-procedure
Incidence of Postoperative Stroke
Time frame: Within 30 days post-procedure
Incidence of Stage ≥2 Acute Kidney Injury (AKI)
Time frame: Within 30 days post-procedure
Operative Metrics
Time frame: Intraoperative
Duration of Mechanical Ventilation
Time frame: During the postoperative hospital stay (up to 30 days post-procedure)
Incidence of Other Major Postoperative Complications
Time frame: During hospital stay (up to 30 days post-procedure)
Change in Aortic Morphology Score
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Change in Quality of Life
Time frame: 3 Months Post-procedure
Incidence of Endoleak
Time frame: 1 Month Post-procedure, 3 Months Post-procedure
Incidence of Cardiovascular Events
Time frame: Through study completion (3 months)
Length of Intensive Care Unit (ICU) Stay
Time frame: During the postoperative hospital stay (up to 30 days post-procedure)
Total Postoperative Hospital Stay
Time frame: During the postoperative hospital stay (up to 30 days post-procedure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-Stop Hybrid Surgery and Conventional Total Arch Replacement with Frozen Elephant Trunk in people with Acute Stanford Type A Aortic Dissection, run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.