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

NCT07518251 | Recruiting

• 1 other identifier: 2023ZD0504403
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracoabdominal Aortic Aneurysm; Cardiopulmonary Bypass; Open Repair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Blood Product Transfusion Volume

  Surgical day and postoperative 1 to 3 days

• Duration of Mechanical Ventilation

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

• Early Mortality

  Postoperative 6 to 12 months

Study Arms (2)

femoro-femoral cardiopulmonary bypass

EXPERIMENTAL

Thoracoabdominal aortic aneurysm repair is performed under fCPB.

Procedure: Thoracoabdominal aortic aneurysm repair under fCPB

left heart bypass

ACTIVE COMPARATOR

Thoracoabdominal aortic aneurysm repair is performed under LHB.

Procedure: Thoracoabdominal aortic aneurysm repair under LHB

Interventions

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.

femoro-femoral cardiopulmonary bypass

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.

left heart bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Guangdong Provincial People's Hospital: collaborator
• Guangzhou First People's Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100013, China

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Su-Wei Chen, Doctor

CONTACT

+86 155 2461 2655; 15524612655@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 8, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)