ClinicalTrials.gg
RecruitingNCT07518251REPAIRUpdated Jul 1, 2026

CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair

An interventional study of Thoracoabdominal aortic aneurysm repair under fCPB and Thoracoabdominal aortic aneurysm repair under LHB in Thoracoabdominal Aortic Aneurysm, Cardiopulmonary Bypass and Open Repair, sponsored by Beijing Anzhen Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.

Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Thoracoabdominal Aortic Aneurysm
  • Cardiopulmonary Bypass
  • Open Repair
03

In context

Aortic Aneurysm, Thoracoabdominal

63 studies on the registry are indexed under Aortic Aneurysm, Thoracoabdominal; 31 are open to participants now.

This study's planned enrollment of 236 is above the median of 80 across 41 interventional studies indexed under Aortic Aneurysm, Thoracoabdominal.

Browse Aortic Aneurysm, Thoracoabdominal studies →

Lead sponsor

Beijing Anzhen Hospital is the lead sponsor of 192 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease;
  2. Adult patients (≥18 years old);
  3. Indications for TAAAR are available and requiring cardiopulmonary bypass;
  4. Signed and availability for follow-up.

Exclusion criteria

Exclusion Criteria:

  1. History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;
  2. History of severe cerebral infarction (with cerebral infarction sequels);
  3. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;
  4. History of infectious aortic diseases;
  5. History of or previous radiotherapy;
  6. Pregnant or feeding women, or anyone planning to reproduce during the test period;
  7. Participating in any other clinical trial;
  8. Having other causes not eligible for operation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
236 participants (estimated)

Study arms

  • Experimental
    femoro-femoral cardiopulmonary bypass

    Thoracoabdominal aortic aneurysm repair is performed under fCPB.

    Procedure: Thoracoabdominal aortic aneurysm repair under fCPB

  • Active comparator
    left heart bypass

    Thoracoabdominal aortic aneurysm repair is performed under LHB.

    Procedure: Thoracoabdominal aortic aneurysm repair under LHB

Interventions

  • ProcedureThoracoabdominal aortic aneurysm repair under fCPB

    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.

  • ProcedureThoracoabdominal aortic aneurysm repair under LHB

    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.

06

What researchers measure

Primary outcomes

  1. Major adverse events

    Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury.

    Time frame: Thirty days and 12 months after the operation

Secondary outcomes

  1. 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

    Time frame: Surgical day and postoperative 1 to 3 days

  2. Duration of Mechanical Ventilation

    time interval between mechanical ventilation and extubation after operation.

    Time frame: Surgical day, postoperative 1 to 3 days, and discharge day / postoperative 30 days.

  3. Early Mortality

    Death occurring after discharge or within 1 year of follow-up

    Time frame: Postoperative 6 to 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Mar 2028, 24 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2026
First posted
Apr 8, 2026
StartActual
Mar 6, 2026
Primary completionEst.
Mar 20, 2028
CompletionEst.
Aug 2028
Last update
Jul 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07518251
Responsible party
Junming Zhu (Vice Chairman, Aortic Surgery Committee of Chinese Association of Cardiovascular Surgeons; President, Beijing Society for Thoracic and Cardiovascular Surgery; Director, Center for Aortic Surgery, Beijing Anzhen Hospital, Beijing Anzhen Hospital) — Principal investigator
First posted
Apr 8, 2026
Start date
Mar 6, 2026
Primary completion
Mar 20, 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jul 1, 2026

Study contacts

Su-Wei Chen, Doctor
Contact
15524612655@163.com
+86 155 2461 2655

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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