Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 67
- 试验地点
- 8
- 主要终点
- Safety - Adverse Events
研究概览
简要总结
This is an investigational study for a new medical device called the nOCT (neuro optical coherence tomography) Imaging System, which is manufactured by Spryte Medical, LLC. The nOCT Imaging System takes pictures from inside a blood vessel in your brain. These pictures give your doctor information about the inside of your blood vessel including the disease and any implanted devices.
The nOCT Imaging System consists of a probe and a console. The probe is a small, flexible wire-like device designed to navigate through catheters which have already been inserted in your body as part of your planned procedure. Catheters are small, flexible, tubes inserted in your blood vessels which allow your doctor to deliver treatments such as medications, coils, or stents directly to the affected area. The console is a unit that includes a computer, screen and laser light source. The probe is connected to the console. The console provides the probe with low-power light from the laser which is used to scan and create pictures of your blood vessel. The pictures are displayed on the screen of the console for review by your doctor and may be stored for future viewing.
The objective of the study is to evaluate the safety and effectiveness of the nOCT Imaging System to provide quality images for diagnostic assessment during endovascular intracranial aneurysm treatment and follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age ≥ 18 and ≤ 75 years
- •Subject has a pre-procedure mRS ≤ 3
- •Subject is undergoing a planned treatment for an intracranial aneurysm, unruptured or ruptured
- •Subject understands the investigational procedure, consents to participation, is willing to comply with study follow-up requirements and provides a signed informed consent document
- •Parent artery has a diameter ≥ 1.3 mm and ≤ 6.0 mm as measured by angiography.
排除标准
- •Subjects with a minimum platelet count of < 100,000/μL.
- •Subjects who have suffered an ischemic stroke or transient ischemic attack within the past 30 days.
- •Subject has an acutely ruptured aneurysm with a Hunt & Hess score ≥ 4
- •Subject has an infectious, blister-like, fusiform, dissecting, traumatic or mycotic aneurysm confirmed by angiography
- •Subject has challenging anatomy that in the investigator's opinion is not suitable for safe delivery of an 0.021" catheter, including stenosis > 70% or excessive tortuosity
- •Subject presents with other medical or surgical co-morbidities limiting his/her life expectancy to less than one year
- •Subject is, in the opinion of the investigator, unlikely to comply with the study protocol or follow-up requirements.
- •Subject with any condition which in the opinion of the treating physician would place the subject at an elevated risk of embolic stroke
- •Subject with known allergy or other contraindication to heparin, iodinated contrast, or dual-antiplatelet medication
- •Subject has ipsilateral carotid or vertebral artery stenosis greater than 50%
- •Subject underwent stenting, angioplasty, or endarterectomy procedures of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment.
- •Subject has serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
- •Subject has severe intracranial vasospasm not responsive to medical therapy
- •Subject has chronic kidney disease stage ≥ 4 and is not undergoing dialysis
- •The subject is pregnant or breastfeeding at the time of admission or plans to become pregnant during their participation in the trial
- •Subject is currently participating in another clinical research trial involving an investigational device or drug
- •Subject is under judicial protection or legal guardianship
研究组 & 干预措施
Single arm: Use of nOCT during treatment and follow-up
Use of nOCT during intracranial aneurysm treatment and subsequent follow-up
干预措施: Endovascular Intracranial aneurysm treatment (Procedure)
Single arm: Use of nOCT during treatment and follow-up
Use of nOCT during intracranial aneurysm treatment and subsequent follow-up
干预措施: nOCT imaging (Device)
结局指标
主要结局
Safety - Adverse Events
时间窗: peri-procedural
All peri-procedural adverse events (AE) from the index procedure.
Effectiveness
时间窗: peri-procedural
Image quality, defined as clear image length (CIL) for images obtained during the index procedure.
次要结局
未报告次要终点