Thoracoabdominal Aortic AneurysmREPAIRNCT07518251
CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair
A study testing Thoracoabdominal aortic aneurysm repair under fCPB and Thoracoabdominal aortic aneurysm repair under LHB in people with Thoracoabdominal Aortic Aneurysm and Cardiopulmonary Bypass, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Cardiopulmonary Bypass, Open Repair
- What is being tested?
- Thoracoabdominal aortic aneurysm repair under fCPB and Thoracoabdominal aortic aneurysm repair under LHB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
- Adult patients (≥18 years old);
- Indications for TAAAR are available and requiring cardiopulmonary bypass;
- Signed informed consent and availability for follow-up.
Who cannot join
- History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
- History of severe cerebral infarction (with cerebral infarction sequels);
- Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
- History of infectious aortic diseases;
- History of malignancy or previous radiotherapy;
- Pregnant or feeding women, or anyone planning to reproduce during the test period;
- Participating in any other clinical trial;
- Having other causes not eligible for operation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100013
Su-Wei Chen, Doctor, +86 155 2461 2655, 15524612655@163.com
About this study
Official title: Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Study Protocol for Multicenter, Two-Arm, Open-Label, Randomized, ParalleI-Controlled Non-Inferiority Trial
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.
- Being tested
- Thoracoabdominal aortic aneurysm repair under fCPB, Thoracoabdominal aortic aneurysm repair under LHB
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoabdominal aortic aneurysm repair under fCPBProcedure or surgery
This procedure is performed under fCPB via femoral artery and vein, inferior vena cava outside the pericardial cavity is alternative choice. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using the arterial tube method. The clamp is deployed at the bilateral iliac bifurcation, the branches of the four-branched graft were anastomosed sequentially in the order of the right renal artery, superior mesenteric artery, celiac trunk, and left renal artery. Finally, the distal end of the four-branched graft was anastomosed to the distal abdominal aorta.
Thoracoabdominal aortic aneurysm repair under LHBProcedure or surgery
This procedure is performed under LHB via the left inferior pulmonary vein and femoral artery. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using the arterial tube method. The clamp is deployed at the bilateral iliac bifurcation, the branches of the four-branched graft were anastomosed sequentially in the order of the right renal artery, superior mesenteric artery, celiac trunk, and left renal artery. Finally, the distal end of the four-branched graft was anastomosed to the distal abdominal aorta.
| Study group | Role | What they receive |
|---|---|---|
| femoro-femoral cardiopulmonary bypass | Experimental | Thoracoabdominal aortic aneurysm repair is performed under fCPB. Receives: Procedure: Thoracoabdominal aortic aneurysm repair under fCPB |
| left heart bypass | Active comparator | Thoracoabdominal aortic aneurysm repair is performed under LHB. Receives: Procedure: Thoracoabdominal aortic aneurysm repair under LHB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury.
Measured: Thirty days and 12 months after the operation
Secondary outcomes (3)
Blood Product Transfusion Volume
volume of blood products transfused from surgical day to postoperative 3 day, including red blood cells, fresh frozen plasma, apheresis platelets and recombinant activated coagulation factor VII
Measured: Surgical day and postoperative 1 to 3 days
Duration of Mechanical Ventilation
time interval between mechanical ventilation and extubation after operation.
Measured: Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days.
Early Mortality
Death occurring after discharge or within 1 year of follow-up
Measured: Postoperative 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start6 Mar 2026
- Primary completion20 Mar 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmStudies 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
- Model description
- The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial.
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Guangdong Provincial People's Hospital, Guangzhou First People's Hospital
- Responsible party
- Principal investigator, Junming Zhu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518251
- Sponsor's protocol ID
- 2023ZD0504403
- Acronym
- REPAIR
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Study Protocol for Multicenter, Two-Arm, Open-Label, Randomized, ParalleI-Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07518251
- Acronym / sponsor ID
- REPAIR / 2023ZD0504403
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, Guangdong Provincial People's Hospital, Guangzhou First People's Hospital
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 8 Apr 2026 (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.
The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| femoro-femoral cardiopulmonary bypass | Experimental | Procedure: Thoracoabdominal aortic aneurysm repair under fCPBThoracoabdominal aortic aneurysm repair is performed under fCPB. |
| left heart bypass | Active comparator | Procedure: Thoracoabdominal aortic aneurysm repair under LHBThoracoabdominal aortic aneurysm repair is performed under LHB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
- Adult patients (≥18 years old);
- Indications for TAAAR are available and requiring cardiopulmonary bypass;
- Signed informed consent and availability for follow-up.
Key exclusion criteria (8 listed)
- History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
- History of severe cerebral infarction (with cerebral infarction sequels);
- Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
- History of infectious aortic diseases;
- History of malignancy or previous radiotherapy;
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 |
|---|---|---|
| Thoracoabdominal aortic aneurysm repair under fCPBThis procedure is performed under fCPB via femoral artery and vein, inferior vena cava outside the pericardial cavity is alternative choice. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using the arterial tube method. The clamp is deployed at the bilateral iliac bifurcation, the branches of the four-branched graft were anastomosed sequentially in the order of the right renal artery, superior mesenteric artery, celiac trunk, and left renal artery. Finally, the distal end of the four-branched graft was anastomosed to the distal abdominal aorta. | Procedure or surgery | femoro-femoral cardiopulmonary bypass |
| Thoracoabdominal aortic aneurysm repair under LHBThis procedure is performed under LHB via the left inferior pulmonary vein and femoral artery. Two clamps were used to occlude the distal aortic arch beyond the left subclavian artery and the proximal descending aorta at the same time. A triple occlusion technique could also be adopted when the aneurysm neck was located high. The proximal abdominal aorta was clamped at the diaphragmatic level after the proximal anastomosis was completed, then intercostal artery reconstruction was performed using the arterial tube method. The clamp is deployed at the bilateral iliac bifurcation, the branches of the four-branched graft were anastomosed sequentially in the order of the right renal artery, superior mesenteric artery, celiac trunk, and left renal artery. Finally, the distal end of the four-branched graft was anastomosed to the distal abdominal aorta. | Procedure or surgery | left heart bypass |
Primary outcome
Major adverse events
Time frame: Thirty days and 12 months after the operation
Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury.
3 secondary outcomes
Blood Product Transfusion Volume
Time frame: Surgical day and postoperative 1 to 3 days
Duration of Mechanical Ventilation
Time frame: Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days.
Early Mortality
Time frame: Postoperative 6 to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoabdominal aortic aneurysm repair under fCPB and Thoracoabdominal aortic aneurysm repair under LHB in people with Thoracoabdominal Aortic Aneurysm and Cardiopulmonary Bypass, run by Beijing Anzhen Hospital 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 8 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: looking for participants now, 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Su-Wei Chen, Doctor (+86 155 2461 2655, 15524612655@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: Thirty days and 12 months after the operation). 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 1 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.