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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiopulmonary Bypass; Thoracoabdominal Aortic Aneurysm; Open Repair
• Intervention / Treatment: Procedure: Thoracoabdominal aortic aneurysm repair under fCPB; Procedure: Thoracoabdominal aortic aneurysm repair under LHB

• Study Type: Interventional
• Enrollment (Estimated): 236
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Su-Wei Chen, Doctor; Phone Number: +86 155 2461 2655; Email: 15524612655@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100013
      • Recruiting
      • Beijing Anzhen Hospital
      • Contact: Su-Wei Chen, Doctor; Phone Number: +86 155 2461 2655; Email: 15524612655@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 informed consent and availability for follow-up.

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 malignancy 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: femoro-femoral cardiopulmonary bypass; Thoracoabdominal aortic aneurysm repair is performed under fCPB.	Procedure: Thoracoabdominal 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.
Active Comparator: left heart bypass; Thoracoabdominal aortic aneurysm repair is performed under LHB.	Procedure: Thoracoabdominal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse events	Major adverse events include surgical mortality, renal replacement treatment, stroke, and spinal cord injury.	Thirty days and 12 months after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Surgical day and postoperative 1 to 3 days
Duration of Mechanical Ventilation	time interval between mechanical ventilation and extubation after operation.	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	Postoperative 6 to 12 months

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: Xiangya Hospital of Central South University; Guangzhou First People's Hospital; Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: 2023ZD0504403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No