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NCT Number: NCT07141251

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

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.

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Key information

Conditions

Thoracoabdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Diseases Cardiovascular Diseases Complex Aortic Aneurysms Endovascular Repair Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

BAO-G

Procedure

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

Primary outcomes

  1. Incidence of primary technical success

    Time frame: within 30 days postoperatively

    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.

  2. Incidence of clinical success

    Time frame: within 5 years postoperatively

    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.

Secondary outcomes

  1. Incidence of aneurysm-related death occurred during perioperative period

    Time frame: within 30 days postoperatively

    All deaths occurring before discharge or within 30 days postoperatively that were attributable to the surgical treatment (including stent-induced retrograde dissection, procedure-related aneurysm rupture, branch occlusion causing severe visceral ischemia, etc.) or aneurysm progression, unless there is clear evidence demonstrating the patient's death was unrelated to the aneurysm.

  2. Incidence of rupture of aneurysms

    Time frame: within 5 years postoperatively

  3. Incidence of permanent paraplegia

    Time frame: within 5 years postoperatively

  4. Incidence of permanent lower limb monoparesis

    Time frame: within 5 years postoperatively

  5. Incidence of new-onset dialysis-dependent renal failure

    Time frame: within 5 years postoperatively

  6. Incidence of severe bowel ischemia

    Time frame: within 5 years postoperatively

  7. Incidence of disabling stroke

    Time frame: within 5 years postoperatively

  8. Intraoperative blood loss

    Time frame: during the operation

  9. Incidence of vascular access complications

    Time frame: within 5 years postoperatively

  10. Operative time

    Time frame: during the operation

  11. Length of stay (LOS)

    Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years

  12. Length of stay for planned staged procedures

    Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years

  13. Incidence of adjunctive primary technical success

    Time frame: within 30 days postoperatively

    Required unplanned additional endovascular techniques (e.g., parallel stent-graft technique) to achieve aneurysm exclusion, without type I/III endoleak and with branch patency for 30 days

  14. Incidence of secondary technical success

    Time frame: within 30 days postoperatively

    Required unplanned surgical conversion to complete aneurysm exclusion, without type I/III endoleak and with branch patency for 30 days.

  15. Incidence of stent migration

    Time frame: within 5 years postoperatively

    Definitive stent migration (≥10mm axial displacement) confirmed by evaluation using anatomical landmarks on the first postoperative CT.

  16. Incidence of aneurysm enlargement

    Time frame: within 5 years postoperatively

    Aneurysm enlargement (>5mm maximum diameter increase) demonstrated on perioperative and follow-up CTA.

  17. Incidence of significant distal embolization

    Time frame: within 5 years postoperatively

    Stent-induced lower limb arterial embolism with ischemia requiring surgical intervention, amputation, or resulting in death.

  18. Incidence of Stent- or procedure-related exploratory laparotomy

    Time frame: within 5 years postoperatively

    Adverse event requiring exploratory laparotomy due to stent- or procedure-related complications

  19. Incidence of aortoiliac stent occlusion

    Time frame: within 5 years postoperatively

    Occlusion of aortic branch stents, iliac branch devices, or iliac limb extensions

  20. Rate of primary stent patency

    Time frame: within 5 years postoperatively

    Patency of branch stents and bridging stents, with no in-stent restenosis or occlusion.

  21. Rate of adjunctive primary stent patency

    Time frame: within 5 years postoperatively

    Secondary intervention was required due to branch/bridging stent kinking or in-stent restenosis, with patency restored after the additional procedure.

  22. Rate of secondary stent patency

    Time frame: within 5 years postoperatively

    Patency restored after secondary intervention for branch/bridging stent occlusion.

  23. Incidence of reoperation

    Time frame: within 5 years postoperatively

    Unplanned reoperation related to stent or procedure within the intended treatment zone, excluding access-related reinterventions and procedures outside the target anatomical area.

  24. Incidence of acute kidney injury

    Time frame: within 30 days postoperatively

    A perioperative increase in serum creatinine to 1.5-2 times the preoperative baseline value according to RIFLE criteria.

  25. Incidence of Type I endoleak

    Time frame: within 5 years postoperatively

    Endoleak originating from proximal or distal seal zones

  26. Incidence of Type Ia endoleak

    Time frame: within 5 years postoperatively

    Endoleak originating from the proximal seal zone of aortic stent

  27. Incidence of Type Ib endoleak

    Time frame: within 5 years postoperatively

    Endoleak originating from the distal seal zone of aortic or iliac stents

  28. Incidence of Type Ic endoleak

    Time frame: within 5 years postoperatively

    Endoleak originating from the distal seal zone of visceral artery stents

  29. Incidence of Type II endoleak

    Time frame: within 5 years postoperatively

    Endoleak originating from aortic branches (e.g., inferior mesenteric artery, lumbar arteries, intercostal arteries)

  30. Incidence of Type III endoleak

    Time frame: within 5 years postoperatively

    Endoleak originating from stent junctions or device structural failure

  31. Incidence of Type IIIa endoleak

    Time frame: within 5 years postoperatively

    Endoleak due to aortoiliac stent junctional failure

  32. Incidence of Type IIIb endoleak

    Time frame: within 5 years postoperatively

    Endoleak caused by fracture or disruption of visceral artery stents within branch vessels

  33. Incidence of Type IIIc endoleak

    Time frame: within 5 years postoperatively

    Endoleak into the aortic aneurysm sac due to poor connection or structural failure between visceral branch bridging stents and aortic branch stents

  34. Incidence of Type IV endoleak

    Time frame: within 5 years postoperatively

    Endoleak due to stent-graft fabric permeability

Study contacts

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

Bao Liu

CONTACT

[email protected]

+86010-69152592

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

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

Registry information

Official study title

Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique

Acronym: BAO-G-02

Important dates

Study start
2022
Primary completion
2030
Study completion
2035
First posted
Aug 26, 2025
Registry last updated
Sep 5, 2025

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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