NCT02816333撤回不适用
Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Major adverse event
研究概览
简要总结
Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.
Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a) In case of acute Type B dissection (14 days from first dissection)
- •Maximum aortic diameter >40 mm or
- •Increase in aortic diameter >2 mm from baseline b) In case of subacute (15~90 days) or chronic (90 days ~ 1 year) Type B
- •Maximum aortic diameter >55 mm or
- •Increase in aortic diameter >4 mm from baseline
- •Age 19-80 years.
- •Aorta anatomy appropriate for stent graft therapy,
- •Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed.
- •Proximal landing zone length >20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta.
- •Declaration of voluntary participation in the study with signed informed consent form.
排除标准
- •Endorgan ischemia or evidence of malperfusion due to aortic dissection
- •Aortic rupture or impeding rupture due to aortic dissection
- •Renal dysfunction with serum Cr level >2.0 mg/dL
- •Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases
- •Uncontrolled active infection or active vasculitis.
- •Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment.
- •Previous thoracic aorta surgery or stent-graft implantation
- •Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
- •Women with positive pregnancy test or at child bearing age
- •Life expectancy <1 year due to comorbidity
结局指标
主要结局
Major adverse event
时间窗: 12 months
A composite of all-cause death, re-intervention, and aortic dilation \> 5 mm in maximal aortic diameter
次要结局
- Aortic remodeling(12 months)
- Aorta-related complications(12 months)
研究者
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