Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)

Официальное название

Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique

Обзор

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.

Вмешательства

• Процедура BAO-G
  Using G-iliac system to reconstruct the visceral branches of in endovascular repair of thoracoabdominal aortic aneurysm.

Первичные конечные точки

• Incidence of primary technical success [Срок оценки: within 30 days postoperatively]
• Incidence of clinical success [Срок оценки: within 5 years postoperatively]

Вторичные конечные точки (12)

• Incidence of aneurysm-related death occurred during perioperative period [Срок оценки: within 30 days postoperatively]
• Incidence of rupture of aneurysms [Срок оценки: within 5 years postoperatively]
• Incidence of permanent paraplegia [Срок оценки: within 5 years postoperatively]
• Incidence of permanent lower limb monoparesis [Срок оценки: within 5 years postoperatively]
• Incidence of new-onset dialysis-dependent renal failure [Срок оценки: within 5 years postoperatively]
• Incidence of severe bowel ischemia [Срок оценки: within 5 years postoperatively]
• Incidence of disabling stroke [Срок оценки: within 5 years postoperatively]
• Intraoperative blood loss [Срок оценки: during the operation]
• Incidence of vascular access complications [Срок оценки: within 5 years postoperatively]
• Operative time [Срок оценки: during the operation]
• Length of stay (LOS) [Срок оценки: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years]
• Length of stay for planned staged procedures [Срок оценки: From the date of hospital admission until the date of hospital discharge, assessed up to 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 11 центров

• Beijing Anzhen Hospital, Capital Medical University — Пекин
• Fuwai Hospital, CAMS&PUMC — Пекин
• Peking Union Medical College Hospital — Пекин
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Hainan General Hospital — Haikou
• The First Affiliated Hospital of Zhengzhou University — Чжэнчжоу
• The Affiliated Hospital of Jining Medical University — Jining
• … и ещё 3 центра

Идентификаторы

NCT: NCT07141251 · BAO-G-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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