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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGHainan General Hospital
Haikou, Hainan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGThe Affiliated Hospital of Jining Medical University
Jining, Shandong, China
RECRUITINGZhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGRenji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITING...and 1 more locations
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.
Time frame: 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.
Time frame: within 5 years postoperatively
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.
Time frame: within 30 days postoperatively
Incidence of rupture of aneurysms
Time frame: within 5 years postoperatively
Incidence of permanent paraplegia
Time frame: within 5 years postoperatively
Incidence of permanent lower limb monoparesis
Time frame: within 5 years postoperatively
Incidence of new-onset dialysis-dependent renal failure
Time frame: within 5 years postoperatively
Incidence of severe bowel ischemia
Time frame: within 5 years postoperatively
Incidence of disabling stroke
Time frame: within 5 years postoperatively
Intraoperative blood loss
Time frame: during the operation
Incidence of vascular access complications
Time frame: within 5 years postoperatively
Operative time
Time frame: during the operation
Length of stay (LOS)
Time frame: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years
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
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
Time frame: 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.
Time frame: 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.
Time frame: within 5 years postoperatively
Incidence of aneurysm enlargement
Aneurysm enlargement (\>5mm maximum diameter increase) demonstrated on perioperative and follow-up CTA.
Time frame: 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.
Time frame: within 5 years postoperatively
Incidence of Stent- or procedure-related exploratory laparotomy
Adverse event requiring exploratory laparotomy due to stent- or procedure-related complications
Time frame: within 5 years postoperatively
Incidence of aortoiliac stent occlusion
Occlusion of aortic branch stents, iliac branch devices, or iliac limb extensions
Time frame: within 5 years postoperatively
Rate of primary stent patency
Patency of branch stents and bridging stents, with no in-stent restenosis or occlusion.
Time frame: 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.
Time frame: within 5 years postoperatively
Rate of secondary stent patency
Patency restored after secondary intervention for branch/bridging stent occlusion.
Time frame: 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.
Time frame: 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.
Time frame: within 30 days postoperatively
Incidence of Type I endoleak
Endoleak originating from proximal or distal seal zones
Time frame: within 5 years postoperatively
Incidence of Type Ia endoleak
Endoleak originating from the proximal seal zone of aortic stent
Time frame: within 5 years postoperatively
Incidence of Type Ib endoleak
Endoleak originating from the distal seal zone of aortic or iliac stents
Time frame: within 5 years postoperatively
Incidence of Type Ic endoleak
Endoleak originating from the distal seal zone of visceral artery stents
Time frame: within 5 years postoperatively
Incidence of Type II endoleak
Endoleak originating from aortic branches (e.g., inferior mesenteric artery, lumbar arteries, intercostal arteries)
Time frame: within 5 years postoperatively
Incidence of Type III endoleak
Endoleak originating from stent junctions or device structural failure
Time frame: within 5 years postoperatively
Incidence of Type IIIa endoleak
Endoleak due to aortoiliac stent junctional failure
Time frame: within 5 years postoperatively
Incidence of Type IIIb endoleak
Endoleak caused by fracture or disruption of visceral artery stents within branch vessels
Time frame: 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
Time frame: within 5 years postoperatively
Incidence of Type IV endoleak
Endoleak due to stent-graft fabric permeability
Time frame: within 5 years postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.