Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- Incidence of primary technical success
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of primary technical success
时间窗: 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
时间窗: 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.
次要结局
- Incidence of aneurysm-related death occurred during perioperative period(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(within 30 days postoperatively)
- Incidence of secondary technical success(within 30 days postoperatively)
- Incidence of stent migration(within 5 years postoperatively)
- Incidence of aneurysm enlargement(within 5 years postoperatively)
- Incidence of significant distal embolization(within 5 years postoperatively)
- Incidence of Stent- or procedure-related exploratory laparotomy(within 5 years postoperatively)
- Incidence of aortoiliac stent occlusion(within 5 years postoperatively)
- Rate of primary stent patency(within 5 years postoperatively)
- Rate of adjunctive primary stent patency(within 5 years postoperatively)
- Rate of secondary stent patency(within 5 years postoperatively)
- Incidence of reoperation(within 5 years postoperatively)
- Incidence of acute kidney injury(within 30 days postoperatively)
- Incidence of Type I endoleak(within 5 years postoperatively)
- Incidence of Type Ia endoleak(within 5 years postoperatively)
- Incidence of Type Ib endoleak(within 5 years postoperatively)
- Incidence of Type Ic endoleak(within 5 years postoperatively)
- Incidence of Type II endoleak(within 5 years postoperatively)
- Incidence of Type III endoleak(within 5 years postoperatively)
- Incidence of Type IIIa endoleak(within 5 years postoperatively)
- Incidence of Type IIIb endoleak(within 5 years postoperatively)
- Incidence of Type IIIc endoleak(within 5 years postoperatively)
- Incidence of Type IV endoleak(within 5 years postoperatively)