ACCESS : ACtive Catheterization for EndovaScular TreatmentS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The cumulative incidence of all adverse events (serious and non-serious)
研究概览
简要总结
The objective of this clinical investigation is to evaluate the safety and technical success of the Basecamp Vascular controllable directional GECKO guidewire when used to facilitate endovascular access to the targeted vessel in order to treat the vascular lesion.
详细描述
The Basecamp Vascular trial is a prospective monocenter, non-randomized, open clinical investigation of their controllable directional GECKO guidewire which has not yet received the CE mark. The GECKO active guidewire is a sterile, single-use device to be used by interventional neuroradiologists (INR) to position a distal access catheter (DAC). The device is a system composed of a deflector (the guide) and a handle. The handle contains the battery and integrated electronics. The device can be activated using buttons on the handle. When the user presses a button, a current is transmitted along the guide to its end: this allows the guide to bend (two possible curves). The end of the device can then take an "S" shape. In INR, the placement of a DAC (at the cervical level) is the first step of an endovascular intervention (Primary Access). This is followed by the treatment phase of the vascular pathology with other medical devices (example: embolization, angioplasty). The GECKO active guide is a system that facilitates endovascular navigation and allows the positioning of the DAC via vascular access (femoral or radial artery). The GECKO device is intended to introduce devices used for treatment, at a desired anatomical location (cervical carotid artery, for example) in the central circulatory system. The GECKO guidewire itself is not meant to perform a treatment but is used to set the primary access that will allow performance of the treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years old.
- •An unruptured intracranial aneurysm, a brain arteriovenous malformation (bAVM) or dural arteriovenous fistula (DAVF) or an internal carotid artery (ICA) stenosis.
- •Subject can receive, if necessary, anti-coagulation and anti-platelet therapy according to the standard used in each study center.
- •Subject is eligible to undergo a procedure with the use of contrast media.
- •Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
- •Subject has given written informed consent.
- •Life expectancy >12 months.
排除标准
- •Subject is unconscious and unable to directly provide his/her written informed consent.
- •Subject with a type 3 aortic arch will be excluded from the study.
- •Subject is or has been treated with radiation therapy to the neck or chest.
- •Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
- •Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFib).
- •Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
- •Subject is unable to complete the required follow-up.
- •Subject is pregnant or breastfeeding. (Females of childbearing potential who are less than 45 years old must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
- •Subject has participated in a clinical study within the last 30 days.
- •Subject with cardiac pacemaker or defibrillator.
- •Persons under guardianship or curatorship.
结局指标
主要结局
The cumulative incidence of all adverse events (serious and non-serious)
时间窗: 30 days
The cumulative incidence of adverse events (serious and non-serious) related to the non-permanent implanted guidewire device or the procedure occurring from Day 1 to 30 days post-procedure. All Serious Adverse Events will be reported (e.g., any thromboembolic event \[intracranial embolus in the targeted vessel territory or other territory, targeted vessel dissection or dissection of any catheterized vessel\], major or minor stroke, or death within 30 days of the intervention).
次要结局
- All-cause mortality.(30 Days)
- Overall Procedure Time(During procedure)
- Number of successful GECKO guidewire placements at the target vessels(During procedure)
- Devices Used(During procedure)
- Measurement of the "time"(During procedure)
- GECKO Procedure Time(During procedure)
- Number of participants with intracranial hemorrhage(30 Days)