Cost Effectiveness, Safety, and Efficacy of the Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment
研究概览
简要总结
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
详细描述
Although coiling has become the most common form of treatment for intracranial aneurysms, there is evidence to suggest that the cost of coiling is on average 50% greater than the cost of clipping. Device costs represent the majority of this increased financial burden. This issue has only increased over time, as supplies and devices accounted for 24% of the increase in hospital costs per discharge from 2001 to 2006. The list price of coils on the US market ranges from $500 to $3000, thus small changes in the number of coils used per case can result in a large cost saving. The Kaneka iED coil is priced within this normal range, but offers a multi-diameter design that may reduce the number of coils required to achieve adequate embolization.
Aside from potential cost savings across all aneurysm types, the ability of the Kaneka iED to both frame and fill with a single coil may prove particularly effective in the treatment of wide-necked aneurysms. In these cases, a wide neck at the base of the aneurysm increased the risk for protrusion of the coil mass back into the normal lumen of the vessel, which can result in stroke and other severe complications. Adjunctive devices such as balloon and stents are often employed to reconstruct the aneurysm neck in these cases, and larger coil mass provided by the Kaneka iED may additionally serve to decrease the risk of coil protrusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patient presenting with ruptured or unruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neuroendovascular treating team
- •Wide neck side wall or bifurcation intracranial aneurysms (neck > or = to 4 mm or dome-to-neck ratio < 2) within the anterior or posterior circulation
- •The neurointerventionist feels that the aneurysm can be safely treated using endovascular techniques (direct or assisted coiling)
- •Patients are 18-80 years of age (inclusive)
- •Patient must be Hunt and Hess grade 0 to 3
- •Patient has given fully informed consent to endovascular coiling procedure. If the patient cannot consent for themselves, appropriate written consent has been sought from their next of kin or appropriate power of attorney.
- •Aneurysm 6-14 mm in diameter
- •Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography) at 3-6 months and 12-18 months after endovascular treatment
- •The patient has not been previously enrolled in this trial or another related ongoing trial
- •The aneurysm has not been previously treated by coiling or clipping
排除标准
- •Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the Kaneka inclusion criteria (i.e., - if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the trial). Non-treated additional aneurysms may be treated at a later date with any coil type that the operator chooses).
- •Target aneurysm has had previous coil treatment or has been surgically clipped
- •Hunt and Hess score is 4 or 5 after subarachnoid hemorrhage
- •Inability to obtain informed consent
- •Medical or surgical comorbidity such that the patient's life expectancy is less than 2 years
研究组 & 干预措施
Matched patients who underwent intracranial aneurysm embolization
The comparator arm will be comprised of propensity matched patients who underwent intracranial aneurysm embolization as part of the FEAT Trial (NCT01655784).
Kaneka i-ED coil
Patients in the experimental arm will be treated according to the standard of care for endovascular aneurysm coiling, with no procedural modifications related to the use of the experimental device.
干预措施: Kaneka i-ED coil (Device)
结局指标
主要结局
Number of patients with Modified Raymond Roy 1-2 Occlusion classification without retreatment
时间窗: at 18 months
Modified Raymond Roy 1-2 occlusion at 18 months without retreatment. The Raymond-Roy Occlusion Classification has 3 responses, where Grade 1 is complete occlusion, no flow of contrast seen in the sac, Grade 2 is partial occlusion, some flow in the neck or sac, and Grade 3 is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
Number of device related serious adverse events
时间窗: 24 hours to 30 days
Intra and peri-procedural (24 hours to 30 days) device related serious adverse event rate.
Number of coils used
时间窗: up to 18 months post-treatment
Number of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
Packing density of coils
时间窗: up to 18 months post-treatment
Packing density of coils used to assess treatment-related cost effectiveness at treatment and over the course of follow-up to 18 months.
次要结局
- Number of patients who suffer a Major ipsilateral stroke or neurological death(at 18 months)
- Ratio of packing density to number of coils used(Treatment, day 1)
- Rate of re-treatment or hemorrhage(at 18 months)
- Rate of complete or near complete aneurysm occlusion without retreatment(at 6 months)
- Number of patients with Modified Raymond-Roy classification 1(at 18 months)
- Aneurysm recurrence/coil compaction(Post-procedure to 18 months)
- Changes in Modified Rankin Scale (mRS) score(Day 30, 6 months, and 12-18 months)
- Changes in National Institutes of Health Stroke Scale (NIHSS) score(Day 30, 6 months, and 12-18 months)
- Raymond-Roy occlusion classification (RROC)(Post-procedure to 18 months)
- Change in Occlusion outcome status(baseline and 18 months)
研究者
Reade De Leacy
Associate Professor, Neurosurgery
Icahn School of Medicine at Mount Sinai