NCT07020611招募中不适用
Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study
Life Seal Vascular Inc.1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年11月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Incidence of major adverse events (MAEs)
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and feasibility of the Cygnum Aneurysm Sac Management Device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). The main questions it aims to answer are:
- Is the Cygnum device safe when used adjunctively with standard EVAR endografts?
- Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac?
Participants will:
- Undergo EVAR with adjunctive implantation of the Cygnum device
- Have follow-up imaging (e.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time
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
- •Patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent
- •Patient is willing to complete the follow-up according to the requirements of the protocol.
- •Patient AAA anatomy complies with "instructions for use" for commercial EVAR devices used
- •≥18 years old
- •Abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females
- •Maximum blood flow luminal diameter ≤ 50mm
- •Eligible for endovascular aneurysm repair based on anatomical considerations, such as adequate iliac/femoral access
- •Patient is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.
排除标准
- •Concomitant Common Iliac Artery aneurysms ≥ 25mm
- •Life expectancy <2 years
- •Already participating in an investigational drug or device study
- •Known allergy or contraindication to any study device material
- •Coagulopathy or uncontrolled bleeding disorder
- •Ruptured, leaking, inflammatory or mycotic aneurysm
- •Connective tissue diseases (e.g., Marfan Syndrome)
- •Unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator
- •Aneurysmal or dissected disease of the descending thoracic aorta
- •Previous surgical or EVAR repair for AAA
- •Myocardial infarction and/or major heart surgery ≤ 90 days prior to the procedure
- •Transient Ischemic Attack or stroke ≤ 90 days prior to the procedure
- •Unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure
- •Unable or unwilling to comply with study follow-up requirements
- •Serum creatinine level ≥ 180 µmol/L
- •Patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study
- •Patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.
结局指标
主要结局
Incidence of major adverse events (MAEs)
时间窗: 30 days post-procedure
Rate of related major adverse events (MAEs)
Procedural Technical Success
时间窗: Immediately after the intervention
Technical success, defined as lining the AAA sac wall with the investigational devices
次要结局
- Incidence of related major adverse events (MAEs)(12 months post procedure)
- Incidence of related serious adverse events (SAEs)(12 months post procedure)
- Efficacy - Type II endoleaks(12 months post procedure)
- Efficacy - AAA sac diameter(12 months post procedure)
研究者
研究点 (1)
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