KCT0003868招募中未知
Prospective multicenter, open, single-design, pivotal clinical study to evaluate the safety and efficacy of open-aortic stent graft treatment for branching vessel protection in patients with aortic dissection, aortic aneurysm, and traumatic aortic injury involving the subclavian artery. Rare Medical Device Trials: 1 branch Type
S&G Biotech0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 70?(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •All of the following criteria must be met to enroll in this trial.
- •In the case of Selection Criteria 1, the selection criterion satisfies the selection criterion 1 even if only one of the criteria 1) to 10) satisfying Euroscore> 6% or more than 60 years of age is applied.
- •1. EuroSCORE> 6% of those aged 70 or older, or those aged 60 or older who have one or more of the following risk ailments
- •1) liver cirrhosis
- •2) pulmonary dysfunction (FEV1 <1L)
- •3) previous heart surgery
- •4) Severe pulmonary hypertension (60mmHg)
- •5) Severe aortic calcification (porcelain aorta)
- •6) Repetitive pulmonary embolism
- •7) Heart failure (Ejection fraction <40%)
- •8) If thoracic burn or mediastinal surgery is not possible with radiation therapy
- •9) Severe connective tissue disease is impossible.
- •10) Severe weight loss patients (Body mass index <18 kg / m2)
- •11) Inability of surgery due to multiple trauma
- •12) If surgery is not possible due to bleeding tendency
- •2. Patients with thoracic aortic aneurysms: diameter greater than 55 mm or complications
- •1) Proximal attachment point 0-15mm (Proximal neck 0-15mm)
- •-> The distance from the left subclavian artery to the rupture area of ??the aortic dissection is 0-15 mm
- •2) Location of aortic aneurysms:
- •A. The procedure is performed when the lesion is located on the inner side of the aorta or on the side (lesser curvature or lat wall).
- •B. In the case of greater curvature of the aorta, a proximal neck of 10 mm or more
- •The procedure is performed.
- •3) The procedure is performed when the distance from the highest part of the aortic arch to the subclavian artery is less than 25mm.
- •(Length from top of aortic arch to lateral wall of left subclavian artery= 25 mm, Fig.A)
- •4) Diameter of iliac artery is=7mm in case of 20 Fr., 22Fr. If the case= 8mm or more is performed.
- •(Iliac artery diameter 20 Fr:= 7 mm, 22 Fr:= 8 mm)
- •3. Patients with descending aortic dissection with complications
- •1) Proximal attachment point 0-15mm (Proximal neck 0-15mm)
- •-> The distance from the left subclavian artery to the rupture area of ??the aortic dissection is 0-15 mm
- •2) Location of aortic rupture:
- •A. If the lesion is located on the inside of the aorta or on the side (lesser curvature or lat wall)
- •B. In the case of greater curvature of the aorta, a proximal neck of 10 mm or more
- •The procedure is performed.
- •3) The procedure is performed when the distance from the highest part of the aortic arch to the subclavian artery is less than 25mm.
- •(Length from top of aortic arch to lateral wall of left subclavian artery = 25 mm, Fig.A)
- •4) Diameter of iliac artery is= 7mm in case of 20 Fr., 22Fr. If the case= 8mm or more is performed.
- •(Iliac artery diameter 20 Fr:= 7 mm, 22 Fr:= 8 mm)
- •4. Traumatic aortic dissection with complications
- •1) Proximal attachment point 0-15mm (Proximal neck 0-15mm)
- •-> The distance from left subclavian artery to traumatic aortic dissection is 0-15 mm
- •2) Location of aortic dissection:
- •A. If the lesion is located on the inside of the aorta or on the side (lesser curvature or lat wall)
- •B. In the case of greater curvature of the aorta, a proximal neck of 10 mm or more
- •The procedure is performed.
- •3) The procedure is performed when the distance from the highest part of the aortic arch to the subclavian artery is less than 25mm.
- •(Length from top of aortic arch to lateral wall of left subclavian artery = 25 mm, Fig.A)
- •4) Diameter of iliac artery is=7mm in case of 20 Fr., 22Fr. If the case= 8mm or more
排除标准
- •Any of the following exclusion criteria will be excluded from this trial.
- •1. The distance from the left subclavian artery to the lesion is not less than 15mm.
- •2. Intraoperative stent graft The diameter of the iliac artery is 24 mm-36 mm. The diameter of the iliac artery is 7 mm or less. The diameter of the iliac artery is less than 8 mm for the stent graft diameter of 38 mm-46 mm. do.
- •Stent graft diameter
- •(stent graft diameter) 24-36mm 38-46mm
- •Iliac artery diameter
- •(iliac artery diameter 7mm or more and 8mm or more
- •3. Severe calcification and angulation of iliac artery.
- •4. The distance from the highest part of the aortic arch to the subclavian artery is 25 mm or more.
- •(Length from top of aortic arch to lateral wall of left subclavian artery> 25 mm)
- •5. The location of the aortic disease is greater in the curvature of the aorta and the proximal neck is less than 10 mm
- •6. If the diameter of the proximal neck of the aorta exceeds 44 mm, the maximum diameter of the open-type stent graft, 46 mm, can not be performed.
- •7. Uncontrolled hypertension
- •8. Unadjusted diabetes (Hb A1c> 10)
- •9. Pregnant women and lactating women (If the woman is not pregnant,
- •10. Patients who do not want to be treated
研究者
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