Aortic Remodeling After Endovascular Management of Type B Aortic Dissection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- technical success
研究概览
简要总结
Assess the clinical outcome, morphological changes and behaviour of type B aortic dissection after endovascular repair.
详细描述
Aortic dissection (AD) is considered the most common catastrophic event of the aorta, and its incidence has been reported to be ≈3/100000 per year, exceeding that of ruptured abdominal aortic aneurysm.
AD is a dynamic process and can occur anywhere along the course of the aorta, with the pathognomonic lesion being an intimal tear followed by blood surging either antegrade (typically) or retrograde, cleaving the the intima and medial layers of the aortic wall longitudinally for a variable distance, thus creating a true and false lumens.
Aortic dissections are classified by chronicity, anatomic location of false lumen, generally the entry tear and longitudinal extent, and the presence or absence of complicating features.
Temporally, AD is categorized as acute phase {<14 days}, subacute {15-90 days}, and chronic {>90 days}.
Thoracic Endovascular Aortic Repair (TEVAR) has emerged as the first-line therapy for the treatment of AD, with better short-term results than open repair due to a significant decrease in perioperative morbidity and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complicated Stanford type B dissections:
- •malperfusion (visceral, extremities or spinal cord ischemia).
- •High-risk aortic dissections:
- •Refractory pain, refractory hypertension or bloody pleural effusion.
- •High-risk radiographic features (max. aortic diameter >40mm, false lumen diameter >22mm, 1ry entry tear >1cm, entry tear location on the lesser curve and radiographic only malperfusin).
- •Aortic anatomy suitable for stent graft therapy:
- •Proximal landing zone (diameters between 15 and 42mm, measured form outer wall to outer wall) isn't aneurysmal, dissected or significantly thrombosed.
- •Proximal landing zone length ≥20mm.
- •Radius of curvature ≥20mm for aortic arch landing zones.
- •Arch or distal aortic angulation 45≤ degrees.
- •Compatible Iliac and/or femoral access vessel morphology (diameter and tortousity) that allows endovascular access to the dissection site with the delivery system of the appropriately sized device, with or without the use of either surigcal or endovascular conduit.
- •Age ≥18yrs.
- •Life expectancy >2yrs
排除标准
- •Known hypersensitivity to device component or contraindication to anticoagulation or contrast media.
- •Systemic or local infection that may increase the risk of endovascular graft infection.
- •Subjects with past descending or abdominal aortic interventions.
- •Un-correctable coagulopathy
- •Active vasculitis
- •Inability or refusal to give informed consent by subject or legal representative
- •Subject is unwilling to comply with the follow-up schedule.
结局指标
主要结局
technical success
时间窗: baseline
successful delivery and deployment of the device with coverage of the 1ry tear at implant with no detected endoleak on angiography
Analysis of aortic remodeling
时间窗: 2 years
evaluation of diameter changes between the preoperative and postoperative CTs measurements in millimetres . The true lumen index (Tli) is calcuated by dividing thr true lumen diameter by the whole lumen (transaortic) diameter. The fasle lumen index (Fli) is calculated in the same manner. The desirable TLi value approaches or equals 1 (suggesting increase in true lumen to normal), whereas the sought-after FLi value approaches or equals 0 (suggesting shrinkage in false lumen).
次要结局
未报告次要终点
研究者
Mohamed hesham abdelrahem husiein
Assistant lecturer
Assiut University