Acute Type A Aortic DissectionMACPNCT07043777
Three-Vessel Versus Unilateral Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection
An observational study of Acute Type A Aortic Dissection, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
This single-centre retrospective observational cohort study describes the technical feasibility of direct three-vessel antegrade cerebral perfusion, designated modified antegrade cerebral perfusion (MACP), during emergency total arch replacement for acute type A aortic dissection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Type A Aortic Dissection
- What is being tested?
- Direct Three-Vessel Antegrade Cerebral Perfusion (MACP) and Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to 1 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital, Taichung, Taiwan, between 1 January 2021 and 30 April 2025. The analytic population was restricted to patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).
Who may be able to join
- Adults aged 18 years or older.
- Patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital between 1 January 2021 and 30 April 2025.
- Patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).
Who cannot join
- Incomplete key clinical, operative, or outcome data precluding analysis.
- Preoperative modified Rankin Scale score of 4 or higher.
- Ischemic stroke within 30 days before surgery.
- Remote prior stroke history or unavailable prior-stroke status.
- Patients managed with cerebral perfusion strategies other than MACP or uACP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Chart-Review Evaluating Direct Three-Vessel Antegrade Cerebral Perfusion Versus Unilateral Right Axillary Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection at CMUH (2021-2025)
This single-centre retrospective observational cohort study describes the technical feasibility of direct three-vessel antegrade cerebral perfusion, designated modified antegrade cerebral perfusion (MACP), during emergency total arch replacement for acute type A aortic dissection. MACP delivers antegrade cerebral perfusion directly to the brachiocephalic, left common carotid, and left subclavian arteries. Outcomes are summarised descriptively and compared exploratorily with unilateral right axillary antegrade cerebral perfusion (uACP). Because perfusion strategy and treating surgeon were completely confounded, the comparative analyses are intended only to contextualise the technical experience and generate hypotheses.
Read the detailed description
Background and Rationale
Acute type A aortic dissection requires emergency surgical repair. When total arch replacement is performed, cerebral protection during circulatory arrest is usually provided with hypothermia and antegrade cerebral perfusion. The optimal branch-level configuration of antegrade cerebral perfusion in emergency arch repair remains uncertain.
This study evaluates a direct three-vessel antegrade cerebral perfusion strategy, designated modified antegrade cerebral perfusion (MACP). MACP was delivered using balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries and connected to a three-line manifold from the cardiopulmonary bypass pump. The comparator was unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation (uACP).
Study Design and Population
This is a single-centre retrospective observational cohort study conducted at China Medical University Hospital, Taichung, Taiwan. Consecutive adults aged 18 years or older who underwent emergency surgical repair for acute type A aortic dissection between 1 January 2021 and 30 April 2025 were identified from electronic health records and intraoperative perfusion records. The manuscript analytic cohort was restricted to patients undergoing emergency total arch replacement with either MACP or uACP.
Objectives
The primary objective is to describe the technical feasibility of MACP during emergency total arch replacement for acute type A aortic dissection. A secondary objective is to provide exploratory contextual outcome comparisons between MACP and uACP. The study is retrospective and observational; the comparative analyses are intended to generate hypotheses rather than to establish treatment effects.
Outcome Measures
The index outcome for the exploratory comparison is postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist. Secondary outcomes include in-hospital mortality, acute kidney injury, new dialysis, reoperation for bleeding, sepsis, postoperative atrial fibrillation, tracheostomy, mechanical ventilation duration, intensive care unit stay, and hospital stay.
Statistical Analysis
Continuous data are summarised as median and interquartile range, and binary data as n/N and percentage. Propensity scores for MACP were estimated using baseline covariates selected a priori and constrained by the small number of MACP patients. The primary exploratory comparison used 1:2 nearest-neighbour propensity score matching without replacement. Binary outcomes were analysed using Firth-penalised logistic regression, and continuous outcomes were compared using non-parametric methods with bootstrap confidence intervals. Sensitivity analyses examined alternative matching specifications, an unmatched propensity-score-adjusted model, and overlap-weighted covariate-balance diagnostics. All analyses are exploratory; p values are descriptive and no adjustment for multiplicity was performed.
Ethics and Oversight
The protocol was approved by the China Medical University Hospital Research Ethics Committee. All data were retrospectively collected and anonymised; informed consent was waived. No U.S. FDA-regulated drug, device, IND, or IDE is involved. Because this is a retrospective chart-review study, a formal data-monitoring committee was not required.
- Conditions
- Acute Type A Aortic Dissection
- Being tested
- Direct Three-Vessel Antegrade Cerebral Perfusion (MACP), Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)
- Keywords
- Cerebral Protection, Neurologic Complications, Retrospective Cohort, Cardiovascular Surgery, China Medical University Hospital, Direct Three-Vessel Antegrade Cerebral Perfusion, Modified Antegrade Cerebral Perfusion, Unilateral Antegrade Cerebral Perfusion, Total Arch Replacement, Acute Type A Aortic Dissection, Postoperative Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Three-Vessel Antegrade Cerebral Perfusion (MACP)Procedure or surgery
Direct antegrade cerebral perfusion through balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries during emergency total arch replacement.
Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)Procedure or surgery
Unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation during emergency total arch replacement.
| Study group | Role | What they receive |
|---|---|---|
| Direct Three-Vessel ACP (MACP) Group | Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom direct three-vessel antegrade cerebral perfusion was delivered to the brachiocephalic, left common carotid, and left subclavian arteries. Receives: Procedure: Direct Three-Vessel Antegrade Cerebral Perfusion (MACP) | |
| Unilateral Right Axillary ACP (uACP) Group | Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom antegrade cerebral perfusion was delivered unilaterally through right axillary artery cannulation. Receives: Procedure: Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Stroke
Postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist.
Measured: During the index admission, up to hospital discharge.
Secondary outcomes (10)
In-Hospital Mortality
Death before discharge during the index admission.
Measured: During the index admission, up to hospital discharge.
Hospital Length of Stay
Length of hospital stay, measured in days from surgery to hospital discharge.
Measured: From surgery to hospital discharge.
ICU Length of Stay
Length of postoperative intensive care unit stay, measured in days from postoperative ICU admission to ICU discharge.
Measured: From postoperative ICU admission to ICU discharge during the index admission.
Mechanical Ventilation Duration
Mechanical-ventilation duration was measured from postoperative intensive-care unit admission to liberation from invasive ventilation.
Measured: During the index admission, up to liberation from invasive ventilation.
Postoperative Acute Kidney Injury (AKI)
Acute kidney injury was defined as KDIGO stage 1 or higher within 7 postoperative days, based on serum creatinine criteria.
Measured: Within 7 postoperative days.
Dialysis Requirement
Requirement for new postoperative renal replacement therapy during the index admission.
Measured: During the index admission, up to hospital discharge.
Number of Participants Requiring Re-operation for Bleeding
Return to the operating room for postoperative bleeding or haematoma evacuation during the index admission.
Measured: During the index admission, up to hospital discharge.
Number of Participants with Sepsis (Sepsis-3)
Sepsis during the index admission, defined according to Sepsis-3 criteria as suspected or documented infection with organ dysfunction.
Measured: During the index admission, up to hospital discharge.
Number of Participants with Postoperative Atrial Fibrillation
Postoperative atrial fibrillation was defined as new-onset atrial fibrillation documented after surgery during the index admission.
Measured: During the index admission, up to hospital discharge.
Tracheostomy
Placement of a tracheostomy after surgery during the index admission.
Measured: During the index admission, up to hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Jan 2021
- Primary completion30 Apr 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- En-Bo Wu, M.D., Principal investigator, Department of Anesthesiology, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043777
- Sponsor's protocol ID
- CMUH114-REC1-089
- Acronym
- MACP
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the dataset was derived from retrospective electronic health records and contains potentially sensitive clinical information. Any external access, if considered, would require separate institutional review and ethics approval.
Publications
Pitts L, Kofler M, Montagner M, Heck R, Iske J, Buz S, Kurz SD, Starck C, Falk V, Kempfert J. Cerebral Protection Strategies and Stroke in Surgery for Acute Type A Aortic Dissection. J Clin Med. 2023 Mar 15;12(6):2271. doi: 10.3390/jcm12062271.
PubMed 36983272
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Chart-Review Evaluating Direct Three-Vessel Antegrade Cerebral Perfusion Versus Unilateral Right Axillary Antegrade Cerebral Perfusion in Emergency Total Arch Replacement for Acute Type A Aortic Dissection at CMUH (2021-2025)
- ClinicalTrials.gov ID
- NCT07043777
- Acronym / sponsor ID
- MACP / CMUH114-REC1-089
- Conditions
- Acute Type A Aortic Dissection
- Keywords
- Cerebral Protection, Neurologic Complications, Retrospective Cohort, Cardiovascular Surgery, China Medical University Hospital, Direct Three-Vessel Antegrade Cerebral Perfusion, Modified Antegrade Cerebral Perfusion, Unilateral Antegrade Cerebral Perfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 29 Jun 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 single-centre retrospective observational cohort study describes the technical feasibility of direct three-vessel antegrade cerebral perfusion, designated modified antegrade cerebral perfusion (MACP), during emergency total arch replacement for acute type A aortic dissection. MACP delivers antegrade cerebral perfusion directly to the brachiocephalic, left common carotid, and left subclavian arteries. Outcomes are summarised descriptively and compared exploratorily with unilateral right axillary antegrade cerebral perfusion (uACP). Because perfusion strategy and treating surgeon were completely confounded, the comparative analyses are intended only to contextualise the technical experience and generate hypotheses.
Detailed description
Background and Rationale
Acute type A aortic dissection requires emergency surgical repair. When total arch replacement is performed, cerebral protection during circulatory arrest is usually provided with hypothermia and antegrade cerebral perfusion. The optimal branch-level configuration of antegrade cerebral perfusion in emergency arch repair remains uncertain.
This study evaluates a direct three-vessel antegrade cerebral perfusion strategy, designated modified antegrade cerebral perfusion (MACP). MACP was delivered using balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries and connected to a three-line manifold from the cardiopulmonary bypass pump. The comparator was unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation (uACP).
Study Design and Population
This is a single-centre retrospective observational cohort study conducted at China Medical University Hospital, Taichung, Taiwan. Consecutive adults aged 18 years or older who underwent emergency surgical repair for acute type A aortic dissection between 1 January 2021 and 30 April 2025 were identified from electronic health records and intraoperative perfusion records. The manuscript analytic cohort was restricted to patients undergoing emergency total arch replacement with either MACP or uACP.
Objectives
The primary objective is to describe the technical feasibility of MACP during emergency total arch replacement for acute type A aortic dissection. A secondary objective is to provide exploratory contextual outcome comparisons between MACP and uACP. The study is retrospective and observational; the comparative analyses are intended to generate hypotheses rather than to establish treatment effects.
Outcome Measures
The index outcome for the exploratory comparison is postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist. Secondary outcomes include in-hospital mortality, acute kidney injury, new dialysis, reoperation for bleeding, sepsis, postoperative atrial fibrillation, tracheostomy, mechanical ventilation duration, intensive care unit stay, and hospital stay.
Statistical Analysis
Continuous data are summarised as median and interquartile range, and binary data as n/N and percentage. Propensity scores for MACP were estimated using baseline covariates selected a priori and constrained by the small number of MACP patients. The primary exploratory comparison used 1:2 nearest-neighbour propensity score matching without replacement. Binary outcomes were analysed using Firth-penalised logistic regression, and continuous outcomes were compared using non-parametric methods with bootstrap confidence intervals. Sensitivity analyses examined alternative matching specifications, an unmatched propensity-score-adjusted model, and overlap-weighted covariate-balance diagnostics. All analyses are exploratory; p values are descriptive and no adjustment for multiplicity was performed.
Ethics and Oversight
The protocol was approved by the China Medical University Hospital Research Ethics Committee. All data were retrospectively collected and anonymised; informed consent was waived. No U.S. FDA-regulated drug, device, IND, or IDE is involved. Because this is a retrospective chart-review study, a formal data-monitoring committee was not required.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct Three-Vessel ACP (MACP) Group | – | Procedure: Direct Three-Vessel Antegrade Cerebral Perfusion (MACP)Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom direct three-vessel antegrade cerebral perfusion was delivered to the brachiocephalic, left common carotid, and left subclavian arteries. |
| Unilateral Right Axillary ACP (uACP) Group | – | Procedure: Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)Patients undergoing emergency total arch replacement for acute type A aortic dissection in whom antegrade cerebral perfusion was delivered unilaterally through right axillary artery cannulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital, Taichung, Taiwan, between 1 January 2021 and 30 April 2025. The analytic population was restricted to patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).
Key inclusion criteria (3 listed)
- Adults aged 18 years or older.
- Patients who underwent emergency total arch replacement for acute type A aortic dissection at China Medical University Hospital between 1 January 2021 and 30 April 2025.
- Patients who received either direct three-vessel antegrade cerebral perfusion (MACP) or unilateral right axillary antegrade cerebral perfusion (uACP).
Key exclusion criteria (5 listed)
- Incomplete key clinical, operative, or outcome data precluding analysis.
- Preoperative modified Rankin Scale score of 4 or higher.
- Ischemic stroke within 30 days before surgery.
- Remote prior stroke history or unavailable prior-stroke status.
- Patients managed with cerebral perfusion strategies other than MACP or uACP.
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 |
|---|---|---|
| Direct Three-Vessel Antegrade Cerebral Perfusion (MACP)Direct antegrade cerebral perfusion through balloon-tipped catheters inserted into the brachiocephalic, left common carotid, and left subclavian arteries during emergency total arch replacement. | Procedure or surgery | Direct Three-Vessel ACP (MACP) Group |
| Unilateral Right Axillary Antegrade Cerebral Perfusion (uACP)Unilateral antegrade cerebral perfusion delivered through right axillary artery cannulation during emergency total arch replacement. | Procedure or surgery | Unilateral Right Axillary ACP (uACP) Group |
Primary outcome
Postoperative Stroke
Time frame: During the index admission, up to hospital discharge.
Postoperative stroke during the index admission, defined as an abrupt focal neurological deficit due to cerebral infarction or intracranial haemorrhage confirmed on postoperative computed tomography or magnetic resonance imaging and adjudicated by a consultant neurologist.
10 secondary outcomes
In-Hospital Mortality
Time frame: During the index admission, up to hospital discharge.
Hospital Length of Stay
Time frame: From surgery to hospital discharge.
ICU Length of Stay
Time frame: From postoperative ICU admission to ICU discharge during the index admission.
Mechanical Ventilation Duration
Time frame: During the index admission, up to liberation from invasive ventilation.
Postoperative Acute Kidney Injury (AKI)
Time frame: Within 7 postoperative days.
Dialysis Requirement
Time frame: During the index admission, up to hospital discharge.
Number of Participants Requiring Re-operation for Bleeding
Time frame: During the index admission, up to hospital discharge.
Number of Participants with Sepsis (Sepsis-3)
Time frame: During the index admission, up to hospital discharge.
Number of Participants with Postoperative Atrial Fibrillation
Time frame: During the index admission, up to hospital discharge.
Tracheostomy
Time frame: During the index admission, up to hospital discharge.
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 1 Jul 2026.
- Background: PubMed 36983272Pitts L, Kofler M, Montagner M, Heck R, Iske J, Buz S, Kurz SD, Starck C, Falk V, Kempfert J. Cerebral Protection Strategies and Stroke in Surgery for Acute Type A Aortic Dissection. J Clin Med. 2023 Mar 15;12(6):2271. doi: 10.3390/jcm12062271.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the dataset was derived from retrospective electronic health records and contains potentially sensitive clinical information. Any external access, if considered, would require separate institutional review and ethics approval.
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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.
En-Bo Wu, M.D. principal investigator
Department of Anesthesiology, China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Type A Aortic Dissection, run by China Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 1 Jul 2026. 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 Taiwan. 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?
Postoperative Stroke (time frame: During the index admission, up to hospital discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07043777, which also lists 1 linked publication.
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 1 Jul 2026.