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NCT Number: NCT07518251

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100013, China

Location status: Recruiting

Location contact

Su-Wei Chen, Doctor

CONTACT

[email protected]

+86 155 2461 2655

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Thoracoabdominal aortic aneurysm repair under fCPB

Procedure

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 LHB

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Blood Product Transfusion Volume

    Time frame: Surgical day and postoperative 1 to 3 days

    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

  2. Duration of Mechanical Ventilation

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

    time interval between mechanical ventilation and extubation after operation.

  3. Early Mortality

    Time frame: Postoperative 6 to 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Su-Wei Chen, Doctor

CONTACT

[email protected]

+86 155 2461 2655

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Collaborators

  • Guangdong Provincial People's Hospital
  • Guangzhou First People's Hospital
  • Xiangya Hospital of Central South University

Registry information

Official study 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

Acronym: REPAIR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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