NL-OMON56955尚未招募不适用
CratosTM Thoracic Branch Stent Graft System is used for the treatment of aortic lesions including aortic dissection, Intramural Hematoma and Penetrating Atherosclerotic Ulcer. - CRATOS
Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd.0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
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
- 18 至 99（—）
入选标准
- •Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and
- •PAU) deemed to warrant surgical repair which requires proximal graft placement
- •2. Age >=18 years at time of informed consent signature
- •3. Informed Consent Form (ICF) is signed by Subject or legal representative
- •4. Must have appropriate proximal aortic landing zone, defined as:
- •Landing zone inner diameters between 23-41 mm
- •The length of landing zone >=15mm
- •Landing without heavily calcified or heavily thrombosed
- •Dissection Patients: Primary entry tear must be distal to LSA, and proximal
- •extent of the proximal landing zone must not be dissected
- •For patients with prior replacement of the ascending aorta and/or aortic arch
- •by a surgical graft, there must be at least 2 cm of landing zone proximal to
- •the most distal anastomosis site.
- •5. Must have appropriate LSA landing zone, defined as:
- •Inner diameters of LSA 5-14 mm
- •Minimum length of Left subclavian artery is 25 mm
- •Target branch vessel landing zone must be in native aorta that cannot be
- •severely tortuous, aneurysmal, dissected, heavily calcified, or heavily
- •thrombosed.
- •6. Must have appropriate distal aortic landing zone, defined as:
- •Aortic inner diameters between 18-41 mm
- •Landing zone cannot be heavily calcified, or heavily thrombosed.
- •For isolated PAU, outer curvature length must be >= 2cm proximal to the celiac
- •Landing zone in native aorta (Note: Bare stent or graft stent implanted
- •during the procedure before investigational device implantation is allowed)
- •Note: In Switzerland, Informed Consent can only be signed by subject
- •Cohort 1 Acute Complicated Type B Aortic dissection (including ULP type) / IMH
- •Patients must meet both of the following:
- •1. Dissection is acute time from symptom onset to dissection diagnosis <=14 days.
- •2. Must present with at least one of the following:
- •- Presence of aortic rupture (either free or contained (including hemothorax,
- •increasing periaortic hematoma, or both; or mediastinal hematoma)
- •- Branch artery occlusion and malperfusion (complete or partial occlusion of a
- •major branch, with or without clinical evidence of ischemia; this includes
- •visceral, renal, and peripheral arterial branches)
- •- Extension of dissection flap either distally or proximally
- •- Aortic enlargement: Progressive enlargement of the true, false, or both lumens
- •- Intractable pain
- •- Uncontrolled hypertension
- •IMH patients must meet both of the following:
- •1. IMH is acute time from symptom onset to IMH diagnosis <=14 days.
- •2. Must present with at least one of the following:
- •- Malperfusion
- •- Periaortic hematoma
- •- Pericardial effusion with cardiac tamponade
- •- Persistent, refractory, or recurrent pain
- •Cohort 2 Non-acute complicated type B Dissection (including ULP type) / IMH and
- •Penetrating aortic ulcer Cohort
- •Non-acute complicated type B dissection (including ULP type) patients must meet
- •one of the following criteria:
- 另有 5 项未显示
排除标准
- •1. Concomitant disease of the ascending aorta or aneurysm of the abdominal
- •aorta requiring repair
- •2. Aortic lesion resulting from Traumatic Transection
- •3. Previous endovascular repair of the ascending aorta
- •4. Surgery within 30 days prior to enrolment with the exception of placement of
- •vascular conduit for access
- •5. Life expectancy <1 years
- •6. Myocardial infarction within 6 weeks prior to treatment
- •7. Stroke within 6 weeks prior to treatment.
- •8. Pregnant or breastfeeding female
- •9. Patient has infected aorta and/or an active systemic infection (e.g.,
- •infection requiring treatment with parenteral anti-infective medication) that
- •may place the patient at increased risk of endovascular infection.
- •10. Degenerative connective tissue disease, e.g., Marfan*s or Ehlers-Danlos
- •11. Participation in another drug or medical device study within one year of
- •study enrolment
- •12. Known history of drug abuse within one year of treatment
- •13. Tortuous or stenotic iliac and/or femoral arteries preventing introducer
- •sheath insertion and the inability to use a conduit for vascular access
- •14. Planned coverage of celiac artery
- •15. Allergic to contrast agents, anesthetics stent graft materials and delivery
- •16. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or
- •known hypersensitivity to heparin
- •17. Patient with a history of a hypercoagulability disorder and/or is currently
- •in a hypercoagulability state
- •18. Persistent refractory shock (systolic blood pressure <90 mm Hg)
- •19. Renal failure defined as patients with an estimated Glomerular Filtration
- •Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis
- •20. Contraindications to antiplatelet drugs and anticoagulants
- •21. Patients aren*t willing to or lacking capacity in the informed consent
- •22. Investigator judged that not suitable for interventional treatment.
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