Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
研究概览
简要总结
The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms.
Participants will:
Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team
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 after 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^6
- •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.^6
- •Patient must be neurologically stable with Hunt & Hess Score of I, II or III.
- •(^6: 6 https://www.ahajournals.org/doi/full/10.1161/STR.0000000000000070)
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) 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 computed tomography (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).
- •Subarachnoid hemorrhage (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.
研究组 & 干预措施
Treatment Attempt with the Contour Neurovascular System
Subjects for which the index procedure (implant of the Contour Neurovascular System) was attempted.
干预措施: Contour Neurovascular System Treatment Attempt (Device)
结局指标
主要结局
Incidence of death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
时间窗: From enrollment to 1 year
Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year. Stroke is defined per the World Health Organization as: rapidly developing clinical signs of focal or global disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke.
Proportion of complete occlusion of the aneurysm with Contour, without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment.
时间窗: From enrollment to 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. The Raymond-Roy Scale grades aneurysms on a scale of one (1) to three (3) with a lower score correlating with a more favorable outcome. The Raymond-Roy Scale will be graded in accordance with the following definitions: Class 1 (Complete obliteration of the aneurysm), Class 2 (Persistence of any portion of the original defect of the arterial wall as seen on any single projection but without opacification of the aneurysmal sac), or Class 3 (Any opacification of the aneurysmal sac).
次要结局
- Proportions of aneurysm occlusion ratings(From enrollment to 2 years)
- Incidence of Serious Adverse Events (SAE) associated with the procedure or device(From enrollment to 2 years)
- Incidence of stroke resulting in a disabling deficit(From enrollment to 2 years)
- Incidence of serious neurological events(From enrollment to 2 years)
- Proportions of device movement ratings(From enrollment to 2 years)