Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)

NCT07141251 | Recruiting Phase 1 DMC

• 1 other identifier: BAO-G-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 11

Brief Summary

Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of complex aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to verify the perioperative safety and 5-year efficacy of BAO-G technique in the endovascular treatment of complex aortic aneurysms through a prospective, multicenter, open-label, single-arm clinical trial, and to provide evidence for the selection of clinical procedures for complex aortic aneurysm patients in the future.

Conditions

Thoracoabdominal Aortic Aneurysm; Endovascular Repair; Complex Aortic Aneurysms

Keywords

BAO-G technique; iliac-branched devices; endovascular repair; complex aortic aneurysm

Outcome Measures

Primary Outcomes (2)

• Incidence of primary technical success

  The preoperative planned protocol was successfully completed, including aneurysm repair and visceral branch reconstruction, with no aneurysm-related conversion to open surgery/death, no type I/III endoleak, and no branch occlusion within 30 days postoperatively.

  within 30 days postoperatively

• Incidence of clinical success

  The preoperative planned protocol was successfully completed, including aneurysm repair and visceral branch reconstruction, without significant disabling permanent clinical sequelae, and with the patient remained free from aneurysm-related mortality or secondary interventions due to aneurysm progression during follow-up.

  within 5 years postoperatively

Secondary Outcomes (34)

• Incidence of aneurysm-related death occurred during perioperative period

  within 30 days postoperatively

• Incidence of rupture of aneurysms

  within 5 years postoperatively

• Incidence of permanent paraplegia

  within 5 years postoperatively

• Incidence of permanent lower limb monoparesis

  within 5 years postoperatively

• Incidence of new-onset dialysis-dependent renal failure

  within 5 years postoperatively

Study Arms (1)

BAO-G group

EXPERIMENTAL

Procedure: BAO-G

Interventions

BAO-G PROCEDURE

Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

BAO-G group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone (\>20mm length, angulation \<60°) in the descending aorta and maximum aneurysm diameter ≥4cm
• Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction
• Signed informed consent and committed to protocol-defined follow-up

You may not qualify if:

• Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
• Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
• Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
• End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
• Active bleeding or coagulopathy within 6 months (high bleeding risk)
• Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
• Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L)
• Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN)
• Concurrent participation in other interventional clinical trials
• Pregnancy or perinatal status
• Refusal to sign informed consent

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Fudan University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Changhai Hospital: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• RenJi Hospital: collaborator
• Hainan General Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Jining Medical University: collaborator

Study Sites (11)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

RECRUITING

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Hainan General Hospital

Haikou, Hainan, 570311, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

The Affiliated Hospital of Jining Medical University

Jining, Shandong, 272000, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, 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

Bao Liu

CONTACT

+86010-69152592; liubao7286@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 26, 2025
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)