JPRN-jRCT2032210226进行中（未招募）3 期
Evaluation of the GA1102-1 in the treatment of lesions of the aorta of the arch and descending thoracic aorta - SSB 11-02
Tanaka Koji0 个研究点目标入组 150 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Presence of thoracic aortic pathology deemed to warrant surgical repair which requires proximal graft placement in Zone 0-2.
- •2)Age equal and over 18 years at time of informed consent signature
- •3)Subject is capable of complying with protocol requirements, including follow-up
- •4)Informed Consent Form (ICF) is signed by Subject or legal representative
- •(a) When enrolling subjects under 20 years of age at a Japanese site, written consent from a legal representative (or substitute) is required in addition to the subject.
- •5)Must have appropriate proximal aortic landing zone.
- •6)Must have appropriate target branch vessel landing zone.
- •7)For patients with aneurysm/isolated lesion, must have appropriate distal aortic landing zone.
- •8)Native aortic valve (Zone 0/1 subjects only)
- •9)Subject is considered a high risk candidate for conventional open surgical repair at the discretion of the Investigator (Zone 0/1 subjects only)
排除标准
- •1)Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- •2)Previous endovascular repair of the ascending aorta
- •3)Previous endovascular repair of the descending thoracic aorta with a non-Gore device
- •4)Surgery within 30 days prior to enrollment, with the exception of surgery for Ascending Aortic Dissection and/or placement of vascular conduit for access.
- •5)Infected aorta
- •6)Life expectancy <2 years
- •7)Myocardial infarction within 6 weeks prior to treatment
- •8)Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin.
- •9)Patient has a systemic infection and may be at increased risk of endovascular graft infection
- •10)Pregnant female at time of informed consent signature
- •11)Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
- •12)Participation in another drug or medical device study within one year of study enrollment
- •13)Known history of drug abuse within one year of treatment
- •14)Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or ascending aorta
- •15)Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- •16)Planned coverage of celiac artery
- •17)Patient has known sensitivities or allergies to the device materials
- •18)Patient has known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
- •19)Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- •20)Patient with a history of a hypercoagulability disorder and/or hypercoagulability state
- •21)Diameter taper outside of the device sizing range between proximal and distal landing zones of aorta and the inability to use additional devices of different diameters to compensate for the taper
- •22)Mycotic aneurysm
- •23)Persistent refractory shock (systolic blood pressure <90 mm Hg)
- •24)Patient has body habitus or other medical condition which prevents adequate visualization of the aorta
- •25)Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 or currently requiring dialysis
- •26)Patient at high risk of neurological event, e.g. stroke
研究者
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