Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Number of subjects with 30-day major adverse events from primary procedure
研究概览
简要总结
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Male or female, aged ≥18 years
- •Expected survival beyond 1 year following successful aneurysm repair
- •Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
- •Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
- •Adequate proximal zone of fixation
- •Adequate distal zone of fixation
- •No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
- •Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary
排除标准
- •Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
- •Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
- •Proximal landing within zone 0 or 1
- •Inability to maintain at least one patent hypogastric artery
- •Freely ruptured aneurysm with hemodynamic instability
- •Non-ambulatory status
- •Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis
- •Unstable angina
- •Stroke or MI within 3 months of planned treatment date
- •Active systemic infection and/or mycotic aneurysm
- •Uncorrectable coagulopathy or other bleeding diathesis
- •Known allergy to device material or contrast material that cannot be adequately pre-medicated
- •Body habitus that would preclude adequate fluoroscopic visualization of aorta
- •Pregnancy or lactation (confirmed per standard of care surgical practice)
- •Major, unrelated surgical procedure planned ≤30 days from endovascular repair
- •Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
- •Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
- •Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
- •Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
结局指标
主要结局
Number of subjects with 30-day major adverse events from primary procedure
时间窗: Day 30
Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation \>72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc
Number of subjects with treatment success
时间窗: Month 12
Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality.
次要结局
- Number of subjects with mortality, major adverse events, spinal cord ischemia(Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60)
- Number of subjects with treatment success and freedom from secondary intervention(Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60)
研究者
Konstantinos Dean Arnaoutakis, MD
Assistant Professor of Surgery
University of South Florida