Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fudan University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Changhai Hospital | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAO-G group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAO-G | Procedure | Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bao Liu | Contact | +86010-69152592 | liubao7286@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100029 | China | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| Beijing Anzhen Hospital | OTHER |
| RenJi Hospital | OTHER |
| Hainan General Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Affiliated Hospital of Jining Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 | 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 | 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. | 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. | within 5 years postoperatively |
| Incidence of aneurysm enlargement | Aneurysm enlargement (>5mm maximum diameter increase) demonstrated on perioperative and follow-up CTA. | 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. | within 5 years postoperatively |
| Incidence of Stent- or procedure-related exploratory laparotomy | Adverse event requiring exploratory laparotomy due to stent- or procedure-related complications | within 5 years postoperatively |
| Incidence of aortoiliac stent occlusion | Occlusion of aortic branch stents, iliac branch devices, or iliac limb extensions | within 5 years postoperatively |
| Rate of primary stent patency | Patency of branch stents and bridging stents, with no in-stent restenosis or occlusion. | 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. | within 5 years postoperatively |
| Rate of secondary stent patency | Patency restored after secondary intervention for branch/bridging stent occlusion. | 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. | 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. | within 30 days postoperatively |
| Incidence of Type I endoleak | Endoleak originating from proximal or distal seal zones | within 5 years postoperatively |
| Incidence of Type Ia endoleak | Endoleak originating from the proximal seal zone of aortic stent | within 5 years postoperatively |
| Incidence of Type Ib endoleak | Endoleak originating from the distal seal zone of aortic or iliac stents | within 5 years postoperatively |
| Incidence of Type Ic endoleak | Endoleak originating from the distal seal zone of visceral artery stents | within 5 years postoperatively |
| Incidence of Type II endoleak | Endoleak originating from aortic branches (e.g., inferior mesenteric artery, lumbar arteries, intercostal arteries) | within 5 years postoperatively |
| Incidence of Type III endoleak | Endoleak originating from stent junctions or device structural failure | within 5 years postoperatively |
| Incidence of Type IIIa endoleak | Endoleak due to aortoiliac stent junctional failure | within 5 years postoperatively |
| Incidence of Type IIIb endoleak | Endoleak caused by fracture or disruption of visceral artery stents within branch vessels | 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 | within 5 years postoperatively |
| Incidence of Type IV endoleak | Endoleak due to stent-graft fabric permeability | within 5 years postoperatively |
| Fuwai Hospital, CAMS&PUMC |
| Recruiting |
| Beijing |
| Beijing Municipality |
| 100037 |
| China |
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
| The First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
| Hainan General Hospital | Recruiting | Haikou | Hainan | 570311 | China |
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
| The Affiliated Hospital of Jining Medical University | Recruiting | Jining | Shandong | 272000 | China |
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided