An Early Feasibility Study Assessing the Safety, Technical Performance, and Efficacy of the Electrolytic eCLIPs Bifurcation System for the Treatment of Intracranial Bifurcation Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Serious Adverse Events following the eCLIPs procedure
研究概览
简要总结
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms. The eCLIPs device is a novel shield like implant that is placed across the neck of the aneurysm and not only facilitates coil retention but also partly obstructs the flow of blood into the aneurysm.
This is an early feasibility study, which is a small study investigating an innovative device to gather more clinical data before conducting a larger study. The safety and the effects of the device on the aneurysm will be studied for 12 months after the procedure among 15 patients at approximately 4 participating hospital centers. A larger study will be required to determine the safety and efficacy of the eCLIPs device for the treatment of wide-necked bifurcation aneurysms.
详细描述
The primary objective of this study is to obtain preliminary confirmation that the eCLIPs Delivery Wire is safe and provides sufficient technical performance in delivering the eCLIPs Implant to distal tortuous anatomies.
This study will be a multicentre, open label, single-arm safety, technical performance, and efficacy study of the Electrolytic eCLIPs Bifurcation System in the management of bifurcated intracranial aneurysms (IA). Subjects included in the study will have saccular intracranial aneurysms that arise at or adjacent to a bifurcation, having a neck length of ≥ 4mm or have a dome:neck ratio <2. Aside from the implantation of the eCLIPs Implant, the study will follow usual clinical care practices.
The subjects will undergo clinical assessments at pre-discharge and 30 days, as well as clinical assessment and radiographic imaging at 6 and 12 months (Digital Subtraction Angiography; DSA).
It is important to note that changes to the investigational device may occur during the course of this early feasibility study. Ongoing results of the study will be evaluated, along with collection of detailed operator feedback on usability, in order to determine whether further refinements to the eCLIPs Delivery Wire are required.
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 with an unruptured or previously ruptured (at least 1 month from date of rupture and with partial occlusion of the dome of the aneurysm by endovascular techniques or by open neurosurgery, and in stable neurological condition-WFNS I and II with a good recovery to at least to mRS 0-2) saccular, intracranial aneurysm or recurrent aneurysm with maximal diameter <25mm and has a neck length of > 4mm or dome:neck ratio <2, arising at a bifurcation with branch artery diameters of 1.5mm to 3.25mm:
- •Patient understands the nature of the procedure and has the capacity to provide informed consent.
- •Patient is willing to have on-site follow-up evaluations up to 5-yrs
- •In the clinician's judgement, the aneurysm requires intervention, given risk of rupture or other rationale (as documented on the Screening CRF), and that the patient agrees with that clinician judgement
排除标准
- •Patient who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
- •Major surgery within previous 30 days or planned within 120 days after enrolment.
- •Patient with an International Normalized Ratio (INR)≥ 1.
- •Patient with serum creatinine level ≥104 μmol/L (or 2.5mg/dL) at time of enrolment.
- •Patient with a platelet count ˂100x103 cells/mm3 or known platelet dysfunction at time of enrolment
- •Patient who has a known cardiac disorder, likely to be associated with cardioembolic symptoms such as atrial fibrillation
- •Patient with any condition that, in the opinion of the treating physician, would place the subject at a high risk of embolic stroke or with any medical co-morbidity likely to affect the outcome (e.g. pulmonary disease, uncontrolled diabetes, blood disorders).
- •Patient with known allergies to nickel-titanium metal
- •Patient with known allergies to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or other anti-platelet or P2Y12 agents or to general anesthesia.
- •Patient with resistance to P2Y12 agents based on a validated platelet testing method (Verify Now, Multiplate or other).
- •Patient with a life-threatening allergy to contrast (patients with itching or rash as a reaction to contrast can be included if properly prophylactically treated).
- •Patient with inappropriate anatomy as demonstrated by angiography due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
- •Patient who is currently participating in another clinical research study involving an investigational product.
- •Patient who has had a previous intracranial procedure associated with the target aneurysm such that access and placement of an eCLIPS device would be compromised
- •Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to the treatment date.
- •More than one intracranial aneurysm that requires treatment within 12 months.
- •Asymptomatic extradural aneurysms requiring treatment.
- •Severe neurological deficit that renders the patient incapable of living independently.
- •Unstable neurological deficit (i.e. worsening or improvement of clinical condition in the last 30 days.
- •Dementia or psychiatric problem that prevents the subject from completing required follow up.
- •Patient had a subarachnoid haemorrhage within 1 month prior to enrolment date.
- •Patient has a non-treated arterio-venous malformation in the territory of the target aneurysm.
- •Patient has a need for long-term use of anticoagulants.
- •Patient who is unable to complete the required follow-up.
- •Inability to understand the study or history of non-compliance with medical advice.
- •Evidence of active infection at the time of treatment.
- •Patient who is pregnant or breastfeeding.
- •Patient who has participated in a drug study within the last 30 days.
结局指标
主要结局
Serious Adverse Events following the eCLIPs procedure
时间窗: Within 30 days of the procedure
Proportion of subjects experiencing a device-related serious adverse event within 30 days following the procedure
次要结局
- Technical Success(During Procedure)
- Success of adjuvant coiling(During Procedure)
- Aneurysm Occlusion(At 6 month and 12 month follow-up)
- Major ipsilateral stroke or neurologic death(Within12 months of procedure)
- All device-related adverse events (AEs)(Within 12 months of procedure)
- Deterioration in modified Rankin Scale (mRS) score at Follow up(30 days, 6, and 12 months following the procedure)
- Assessment of implant migration(6 and 12 months following procedure)
- Assessment of branch artery patency(6 and 12 months following procedure)
- Patient Outcomes - Hospitalization length of stay (LOS)(Within 12 months of procedure)
- Patient Outcomes - Subsequent hospitalization(Within 12 months of procedure)
- Patient Outcomes - Remedial actions required(Within 12 months of procedure)
- Patient Outcomes - Reintervention required(30 days, 6, and 12 months following the procedure)
- Patient Outcomes - Return to baseline or improved functioning(6 and 12 months following procedure)
- Patient Outcomes - Aneurysm recurrence(Within 30 days, 6, and 12 months following the procedure)
- Patient Outcomes - Aneurysm rupture(Within 30 days, 6, and 12 months following the procedure)
- Patient Outcomes - Neurologic deterioration(Immediate post-procedure prior to discharge)