US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
- 试验地点
- 40
- 主要终点
- Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
研究概览
简要总结
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.
详细描述
The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device. This trial is a prospective, multicenter single-arm study. Up to 220 subjects will be enrolled at up to 20 participating investigational sites.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-75 years of age at the time of screening.
- •Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.
- •The target IA must have the following characteristics:
- •Saccular morphology
- •Located at a bifurcation in the anterior or posterior circulation
- •Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm
- •Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2
- •Patient may be treated with Contour without the use of additional implanted devices.
- •Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
- •Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures.
- •FOR PATIENTS WITH UNRUPTURED ANEURYSM
- •Patient meets the criteria outlined in the "Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms" as published by the AHA/ASA FOR PATIENTS WITH RUPTURED ANEURYSM
- •Patient meets the criteria outlined in the "Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association" as published by the AHA/ASA.
- •Patient must be neurologically stable with Hunt & Hess Score of I, II or III.
排除标准
- •Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
- •Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
- •Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
- •Contraindication to anticoagulants or anti-platelet medications
- •Stenosis of the target IA's parent vessel is >50%
- •Anticoagulation medications (e.g., warfarin) that cannot be discontinued
- •Acute / chronic renal failure (unless on dialysis) and/or creatinine > 2.00 mg/dl or > 182 μmol/L
- •Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- •Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
- •Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days.
- •Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder).
- •modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable).
- •SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days.
- •Physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
- •Pregnant, breastfeeding or planning pregnancy in the next 2 years
- •Subject is enrolled in another device or drug study in which participation could confound study results.
- •Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm.
结局指标
主要结局
Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.
时间窗: 1 year
Complete occlusion of the aneurysm with Contour as defined by complete aneurysm occlusion (Raymond Roy Scale , of 1) without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (\> 50% stenosis) at one (1) year after treatment as assessed by the angiographic core laboratory.
Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
时间窗: 30 days
Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
次要结局
- Key Secondary Effectiveness Endpoint(1 year)
- Key Secondary Safety Endpoint(1 year)