Complex Endovascular Aortic Repair in Inflammatory and Infective Perivisceral Abdominal Aortic Aneurysms and Thoracoabdominal Aortic Aneurysms (CEVARII)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Conversion to Open Surgical Repair (OSR)
研究概览
简要总结
Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. Ethical approval for the study was obtained from the Colorado Multiple Institutional Review Board (COMIRB) under protocol number 23-1533.
详细描述
Infective Native and Inflammatory Aortic Aneurysms (INAA & IAA) are rare, morbid conditions with unique challenges. INAA & IAA share clinical and imaging similarities but differ significantly in pathophysiology, management, and prognosis. Open surgical repair of INAA & IAA is technically challenging and associated with higher complications.
Complex endovascular aortic repair in inflammatory and infective perivisceral abdominal aortic aneurysms and thoracoabdominal aortic aneurysms (CEVARII) study is a collaborative international consortium effort among vascular surgeons to establish a database on the global experience in the management of INAAs and IAAs. CEVARII study is IRB approved with the number 23-1533.
Knowledge gained will help generate consensus on how to best manage patients with inflammatory and infective aortic aneurysms involving the visceral and thoracoabdominal aorta.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years old with a diagnosis of inflammatory abdominal aortic aneurysm (IAA) or infective native aortic aneurysms (INAA), who have undergone complex endovascular aortic repair (cEVAR) are eligible for inclusion in this study.
排除标准
- •Suboptimal documentation of clinical, laboratory, and imaging findings
- •Presence of prosthetic material (endograft or open graft material)
- •Prior open or endovascular aortic repair
- •Findings suspicious of secondary aorto-enteric or -bronchial fistulas.
结局指标
主要结局
Conversion to Open Surgical Repair (OSR)
时间窗: up to 30 days
Outcome measures include the number of participants whose cases converted from endovascular aortic aneurysm repair to open surgical repair.
Primary Graft Patency
时间窗: up to 36 months
Defined as uninterrupted blood flow with no interventions. Follow-up timeframes - 1, 6, 12, 24, and 36 months
Aneurysm-related mortality (ARM)
时间窗: up to 30 days
Outcome measures include the number of participants who died 30 days after the procedure.
Bowel Ischemia
时间窗: 30 days
Bowel Ischemia requiring surgical resection/not resolving with medical therapy. Outcome measures include the number of Participants with bowel ischemia after surgery.
Presence of aortic aneurysm endoleak after surgery
时间窗: up to 30 days
The technical repair success is defined as the exclusion of the aneurysm without Type I/III endoleak, and with preservation of at least the Superior Mesenteric Artery or the Celiac Artery. Outcome measures include the number of participants with type I endoleak, and the number of participants with type III endoleak.
Aortic rupture
时间窗: up to 30 days.
Outcome measures include the number of participants who had aortic rupture.
Post-operative infection-related complication (IRC)
时间窗: up to 24 months
Outcome measures include the number of participants who had a new post-operative infection-related complication (IRC) in treated aortic segments or endograft, new IRC in contiguous aortic segments, or persistent sepsis.
The duration of preoperative, perioperative, and postoperative duration of anti-microbial or immunosuppressive pharmacologic therapies.
时间窗: up to 36 months
Duration of antibiotics (in days) prescribed for Infective aortic aneurysm patients before and after the surgery. Duration of immunosuppressive drugs (in days) for inflammatory aortic aneurysm patients before and after the surgery
次要结局
- Continued Aortic sac growth.(up to 24 months)
- All Cause Mortality(24 months)
- Assessment of Adverse Events (AEs) described in the protocol.(up to 36 months)
研究者
Mel J. Sharafuddin, MD, FACS, FSIR
Clinical Professor of Surgery and Radiology
University of Colorado, Colorado Springs