Complex Aortic Aneurysms, Endovascular Repair, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
BAO-G technique, iliac-branched devices, endovascular repair, complex aortic aneurysm
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.
Interventions
PROCEDUREBAO-G
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Sponsors
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
The Affiliated Hospital of Jining Medical University
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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 2. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction 3. Signed informed consent and committed to protocol-defined follow-up
Exclusion criteria
1. Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent 2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis) 3. Prior aortic surgery with stent-graft or prosthetic vascular graft implantation 4. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up 5. Active bleeding or coagulopathy within 6 months (high bleeding risk) 6. Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg) 7. Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L) 8. Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN) 9. Concurrent participation in other interventional clinical trials 10. Pregnancy or perinatal status 11. Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of primary technical success | 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. |
| Incidence of clinical success | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Incidence of severe bowel ischemia | within 5 years postoperatively | — |
| Incidence of disabling stroke | within 5 years postoperatively | — |
| Intraoperative blood loss | during the operation | — |
| Incidence of vascular access complications | within 5 years postoperatively | — |
| Operative time | during the operation | — |
| Length of stay (LOS) | From the date of hospital admission until the date of hospital discharge, assessed up to 5 years | — |
| Length of stay for planned staged procedures | From the date of hospital admission until the date of hospital discharge, assessed up to 5 years | — |
| Incidence of adjunctive primary technical success | 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 |
| Incidence of secondary technical success | within 30 days postoperatively | Required unplanned surgical conversion to complete aneurysm exclusion, without type I/III endoleak and with branch patency for 30 days. |
| Incidence of stent migration | within 5 years postoperatively | Definitive stent migration (≥10mm axial displacement) confirmed by evaluation using anatomical landmarks on the first postoperative CT. |
| Incidence of aneurysm enlargement | within 5 years postoperatively | Aneurysm enlargement (\>5mm maximum diameter increase) demonstrated on perioperative and follow-up CTA. |
| Incidence of significant distal embolization | within 5 years postoperatively | Stent-induced lower limb arterial embolism with ischemia requiring surgical intervention, amputation, or resulting in death. |
| Incidence of Stent- or procedure-related exploratory laparotomy | within 5 years postoperatively | Adverse event requiring exploratory laparotomy due to stent- or procedure-related complications |
| Incidence of aneurysm-related death occurred during perioperative period | 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. |
| Rate of primary stent patency | within 5 years postoperatively | Patency of branch stents and bridging stents, with no in-stent restenosis or occlusion. |
| Rate of adjunctive primary stent patency | 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. |
| Rate of secondary stent patency | within 5 years postoperatively | Patency restored after secondary intervention for branch/bridging stent occlusion. |
| Incidence of reoperation | 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. |
| Incidence of acute kidney injury | within 30 days postoperatively | A perioperative increase in serum creatinine to 1.5-2 times the preoperative baseline value according to RIFLE criteria. |
| Incidence of Type I endoleak | within 5 years postoperatively | Endoleak originating from proximal or distal seal zones |
| Incidence of Type Ia endoleak | within 5 years postoperatively | Endoleak originating from the proximal seal zone of aortic stent |
| Incidence of Type Ib endoleak | within 5 years postoperatively | Endoleak originating from the distal seal zone of aortic or iliac stents |
| Incidence of Type Ic endoleak | within 5 years postoperatively | Endoleak originating from the distal seal zone of visceral artery stents |
| Incidence of Type II endoleak | within 5 years postoperatively | Endoleak originating from aortic branches (e.g., inferior mesenteric artery, lumbar arteries, intercostal arteries) |
| Incidence of Type III endoleak | within 5 years postoperatively | Endoleak originating from stent junctions or device structural failure |
| Incidence of Type IIIa endoleak | within 5 years postoperatively | Endoleak due to aortoiliac stent junctional failure |
| Incidence of Type IIIb endoleak | within 5 years postoperatively | Endoleak caused by fracture or disruption of visceral artery stents within branch vessels |
| Incidence of Type IIIc endoleak | 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 |
| Incidence of Type IV endoleak | within 5 years postoperatively | Endoleak due to stent-graft fabric permeability |
| Incidence of aortoiliac stent occlusion | within 5 years postoperatively | Occlusion of aortic branch stents, iliac branch devices, or iliac limb extensions |
| Incidence of rupture of aneurysms | within 5 years postoperatively | — |
Countries
China
Contacts
Primary ContactBao Liu
Outcome results
None listed