Prospective, Open-label, Multicenter, Non-randomized Clinical Study to Determine the Safety and Efficacy of SETA LATECBA Stent Graft for Endovascular Repair Therapy (EVAR) in Subjects With Abdominal Aortic Aneurysm (AAA).
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)
研究概览
简要总结
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study. The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of EVAR of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure).Other objective is to evaluate the technical performance of the device SETA LATECBA Stent Graft.
详细描述
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study to determine the Safety and Efficacy of the SETA LATECBA Stent Graft for endovascular repair therapy (EVAR) in Subjects with Abdominal Aortic Aneurysm (AAA)..The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the treatment of Endovascular Aneurysm Repair (EVAR) of pararenal AAA (patients with complex anatomy, not eligible for other surgical procedure).
Secondary objective(s): The secondary objective is to evaluate the technical performance of the device SETA. LATECBA Stent Graft which includes: access to the implantation site, visualization, deployment of the stent- graft, sizing compatibility, withdrawal of the delivery system, and compatibility with ancillary equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults older than 18 years old, willing to cooperate with the study. No other demographic restriction.
- •Initial diagnosis of AAA according to the standard of care criteria following the guidance Clinical Practice Guidelines for Endovascular Abdominal Aortic Aneurysm Repair
- •Medical history: Complete history of previous, present and concomitant conditions, and current treatments for other conditions Signed informed consent. If the patient cannot consent, the subject's legally acceptable representative should consent
- •Diagnosis of Abdominal Aortic Aneurysm (AAA) according to the following criteria:
- •Diagnosis of an abdominal aortic aneurysm with a diameter ≥ 5.0 cm for males or ≥ 4.5 cm for females.
- •Aneurysm diameter with a growth rate ≥ 0.5 cm/ 6 months
- •The juxtarenal neck length between 1 mm and 10 mm
- •Neck diameter ≥16 to ≤ 26 mm
- •Suprarenal aorta diameter ≥ infrarenal aorta diameter
- •Proximal neck angulated ≤ 60 degrees relative to the long axis of the aneurysm
- •Immediate suprarenal aorta angulated ≤ 60 degrees relative to the immediate infrarenal neck.
- •Common iliac diameter 8 to 20 mm.
- •Common iliac length 25 mm
- •Common iliac angle 60 degrees
- •Not eligible for other standard EVAR surgical procedure
排除标准
- •General Exclusion Criteria
- •Life expectancy less than 2 years
- •Pregnant or breastfeeding or planning on becoming pregnant within 60 months
- •Included in another investigative drug or device study/studies or planning to do it within the following 24 months
- •Medical Exclusion Criteria
- •Previous treatment of AAA
- •Known allergy to polyester, stainless steel, nitinol and or gold, teflon, nylon,
- •Known anaphylactic reaction to contrast media.
- •Any type coagulopathy untreated.
- •Genetic connective tissue diseases, such as Marfan or Ehlers-Danlos syndromes
- •Planned interventional or surgical procedure within 30 days before or after AAA repair.
- •Renal dysfunction: creatinine level over 1.7 mg/dl
- •Systemic infection or fever over 38°C
- •AAA Anatomy Exclusion Criteria
- •Significant occlusive disease, tortuosity, or calcification.
- •i) Significant thrombus in the fixation sites. j) Fungal aneurysm k) Leaking/ruptured or symptomatic aneurysm. l) Traumatic aneurysm. m) Concurrent aneurysm of the thoracic aorta. n) One or both renal arteries coming from the aneurysmal sac. o) Proximal neck diameter, measured outer wall to outer wall on a sectional image (CTA) > 26 mm in diameter or < 16 mm in diameter p) Proximal neck angle > 60 degrees relative to the long axis of the aneurysm q) Immediate suprarenal aorta angle > 60 degrees relative to the immediate infrarenal neck.
- •r) Immediate suprarenal aorta angle > 60 degrees relative to the immediate infrarenal neck s) Aortic diameter, measured inner wall to inner wall on a sectional image (CTA) < 15 mm at the bifurcation t) Iliac/femoral anatomy that is unsuitable for access. u) Iliac artery diameter, measured outer wall to outer Wall on a sectional image (CTA) > 20 mm or < 8 mm at distal fixation site.
- •v) Iliac artery distal fixation site < 10 mm in length. w) Indispensable inferior mesenteric artery (IMA)
结局指标
主要结局
EFFICACY: Number of participants with Endoleak Type I (measured by Angio CT Scan)
时间窗: 30 days
Type I endoleaks is diagnosed when there is a gap between the stent graft and the vessel wall. Usually is a result of the failure of the stent graft to achieve a circumferential seal of the aneurism. It produces systemic pressurization of the aneurysm sac and increases the risk of sac rupture.
SAFETY: mortality
时间窗: 30-day
percentage of died subjects
次要结局
- Incidence of post-operative complications(12 months)
- Clinical success(12 months)
- SAFETY: Major Adverse Events(30-day)
- Technical Success of stent-graft implantation and delivery system usage(12 months)