Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 9
- 主要终点
- Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment.
研究概览
简要总结
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour").
The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.
详细描述
Contour Neurovascular System™ European Pre-Market Unruptured Aneurysm Study (CERUS) initiated enrollment in October 2018 to assess the safety and effectiveness of the Contour Neurovascular System ("Contour") in treatment of intracranial aneurysms (IA) with the intended indication for endovascular embolization of saccular IA. This prospective, single-arm, multicenter study was conducted to document the safety and performance of the Contour in treatment for patients with an IA.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all genders who meet all indications and contraindications will proceed to implantation.
- •Inclusion criteria
- •Patient's indication for treatment of unruptured aneurysm is according to the national/international guidelines.
- •Age 18-80 years at screening
- •Patients who are suitable for non-emergency endovascular embolization of saccular IAs
- •IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU
- •Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements
- •Patient able to able to give their informed consent can be included in this study. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
排除标准
- •The presence of condition that may create unacceptable risk during the aneurysm embolization procedure, such as patients with:
- •Ruptured aneurysm
- •Patient anatomy or physiology considered unsuitable for endovascular treatment
- •Contraindication for arterial access
- •Largest measured IA equatorial diameter >8.5 mm or <2 mm
- •Largest measured IA neck diameter >8 mm or <2 mm
- •Target IA contains other devices/implants (e.g., coils)
- •Known allergy to platinum, nickel or titanium
- •Known allergy to contrast agents
- •Contraindication to anticoagulants or platelet inhibitor medication
- •Stenosis of the target IA's parent vessel >50%
- •Anticoagulation medications such as warfarin that cannot be discontinued
- •Pregnant, breastfeeding or planning pregnancy in the next 2 years
- •Acute / chronic renal failure (including dialysis); Creatinine > 2.00 mg/dl or > 182 μmol/L
- •Myocardial Infarction, Stroke or TIA within the last 6 months
- •Any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc.
- •Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.)
- •Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes
结局指标
主要结局
Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment.
时间窗: 6 months
The Primary Safety Endpoint is the percentage of subjects with death of any non-accidental cause or any major disabling stroke within the first 30 days after treatment or major disabling stroke or death due to neurological cause from day 31 to 6 months after treatment. Major Disabling Stroke is defined as an episode of neurological signs or symptoms that persist beyond 24 hours accompanied with evidence of ischemia/infarction on imaging that results in an increase of NIHSS from baseline by \>= 4 points and/or an increase from mRS baseline by \>2. An independent Clinical Events Committee adjudicated all data used for safety endpoint analyses.
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months.
时间窗: 6 months
The Primary Performance Endpoint was the percentage of subjects with complete aneurysm occlusion at 6 months as adjudicated by an independent core laboratory. Occlusion was assessed using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).
次要结局
未报告次要终点