Thoracoabdominal Aortic AneurysmBAO-G-02NCT07141251
Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)
A study testing BAO-G in people with Thoracoabdominal Aortic Aneurysm and Endovascular Repair, run by Peking Union Medical College Hospital at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm, Endovascular Repair, Complex Aortic Aneurysms
- What is being tested?
- BAO-G
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesChina
- Study dates
- 1 Jan 2022to 31 Dec 2035
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Crawford type Ⅰ- Ⅴ 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
- Patients with pseudoaneurysms, post-dissection aneurysmal degeneration, or failure of previous EVAR were also eligible if the pathology involved the visceral aortic segment;
- 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
Who cannot join
- Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
- Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
- 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)
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- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
- Recruiting
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Bao Liu, +86010-69152592, liubao7286@163.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
- Recruiting
Hainan General Hospital
Haikou, Hainan, 570311
- Recruiting
The Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
- Recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique
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.
- Being tested
- BAO-G
- Keywords
- BAO-G technique, iliac-branched devices, endovascular repair, complex aortic aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAO-GProcedure or surgery
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
| Study group | Role | What they receive |
|---|---|---|
| BAO-G group | Experimental | Not described Receives: Procedure: BAO-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 5 years postoperatively
Secondary outcomes (34)
Incidence of aneurysm-related death occurred during perioperative period
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.
Measured: within 30 days postoperatively
Incidence of rupture of aneurysms
Measured: within 5 years postoperatively
Incidence of permanent paraplegia
Measured: within 5 years postoperatively
Incidence of permanent lower limb monoparesis
Measured: within 5 years postoperatively
Incidence of new-onset dialysis-dependent renal failure
Measured: within 5 years postoperatively
Incidence of severe bowel ischemia
Measured: within 5 years postoperatively
Incidence of disabling stroke
Measured: within 5 years postoperatively
Intraoperative blood loss
Measured: during the operation
Incidence of vascular access complications
Measured: within 5 years postoperatively
Operative time
Measured: during the operation
Length of stay (LOS)
Measured: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years
Length of stay for planned staged procedures
Measured: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years
Incidence of adjunctive primary technical success
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
Measured: within 30 days postoperatively
Incidence of secondary technical success
Required unplanned surgical conversion to complete aneurysm exclusion, without type I/III endoleak and with branch patency for 30 days.
Measured: within 30 days postoperatively
Incidence of stent migration
Definitive stent migration (≥10mm axial displacement) confirmed by evaluation using anatomical landmarks on the first postoperative CT.
Measured: within 5 years postoperatively
Incidence of aneurysm enlargement
Aneurysm enlargement (>5mm maximum diameter increase) demonstrated on perioperative and follow-up CTA.
Measured: within 5 years postoperatively
Incidence of significant distal embolization
Stent-induced lower limb arterial embolism with ischemia requiring surgical intervention, amputation, or resulting in death.
Measured: within 5 years postoperatively
Incidence of Stent- or procedure-related exploratory laparotomy
Adverse event requiring exploratory laparotomy due to stent- or procedure-related complications
Measured: within 5 years postoperatively
Incidence of aortoiliac stent occlusion
Occlusion of aortic branch stents, iliac branch devices, or iliac limb extensions
Measured: within 5 years postoperatively
Rate of primary stent patency
Patency of branch stents and bridging stents, with no in-stent restenosis or occlusion.
Measured: within 5 years postoperatively
Rate of adjunctive primary stent patency
Secondary intervention was required due to branch/bridging stent kinking or in-stent restenosis, with patency restored after the additional procedure.
Measured: within 5 years postoperatively
Rate of secondary stent patency
Patency restored after secondary intervention for branch/bridging stent occlusion.
Measured: within 5 years postoperatively
Incidence of reoperation
Unplanned reoperation related to stent or procedure within the intended treatment zone, excluding access-related reinterventions and procedures outside the target anatomical area.
Measured: within 5 years postoperatively
Incidence of acute kidney injury
A perioperative increase in serum creatinine to 1.5-2 times the preoperative baseline value according to RIFLE criteria.
Measured: within 30 days postoperatively
Incidence of Type I endoleak
Endoleak originating from proximal or distal seal zones
Measured: within 5 years postoperatively
Incidence of Type Ia endoleak
Endoleak originating from the proximal seal zone of aortic stent
Measured: within 5 years postoperatively
Incidence of Type Ib endoleak
Endoleak originating from the distal seal zone of aortic or iliac stents
Measured: within 5 years postoperatively
Incidence of Type Ic endoleak
Endoleak originating from the distal seal zone of visceral artery stents
Measured: within 5 years postoperatively
Incidence of Type II endoleak
Endoleak originating from aortic branches (e.g., inferior mesenteric artery, lumbar arteries, intercostal arteries)
Measured: within 5 years postoperatively
Incidence of Type III endoleak
Endoleak originating from stent junctions or device structural failure
Measured: within 5 years postoperatively
Incidence of Type IIIa endoleak
Endoleak due to aortoiliac stent junctional failure
Measured: within 5 years postoperatively
Incidence of Type IIIb endoleak
Endoleak caused by fracture or disruption of visceral artery stents within branch vessels
Measured: within 5 years postoperatively
Incidence of Type IIIc endoleak
Endoleak into the aortic aneurysm sac due to poor connection or structural failure between visceral branch bridging stents and aortic branch stents
Measured: within 5 years postoperatively
Incidence of Type IV endoleak
Endoleak due to stent-graft fabric permeability
Measured: within 5 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jan 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, First Affiliated Hospital, Sun Yat-Sen University, Changhai Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital, Beijing Anzhen Hospital, RenJi Hospital, Hainan General Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Chongqing Medical University, Affiliated Hospital of Jining Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141251
- Sponsor's protocol ID
- BAO-G-02
- Acronym
- BAO-G-02
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No