ENTERPRISE 2 Vascular Reconstruction Device and Delivery System Registry: A Multicenter, Prospective, Single-arm Observational Study to Evaluate the Safety and Effectiveness With the Device to Facilitate Endovascular Coil Embolization of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 164
- 试验地点
- 16
- 主要终点
- Incidence of aneurysm recanalization
研究概览
简要总结
The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of intracranial aneurysms.
详细描述
This is a prospective, multicenter, single-arm observational study, in which enrolled patients will be implanted with the ENTERPRISE 2 for evaluation of safety and effectiveness of ENTERPRISE 2 in real-world applications.
The study population will consist of 164 patients with ruptured or unruptured intracranial aneurysms and a parent vessel diameter of ≥2.5 mm and ≤4 mm. All patients will be implanted with the study device.
The enrolled patients will be followed at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure.
The primary endpoint is the incidence of aneurysm recanalization (at 180 days) evaluated through digital subtraction angiography (DSA). Secondary effectiveness endpoints include incidence of aneurysm recanalization (at 1 year), successful stent/coil placement rate (immediately post procedure), aneurysm occlusion (immediately post procedure, at 180 days and 1 year), incidence of retreatment (at 30 and 180 days, and 1, 2, 3, 4 and 5 years). Safety evaluation include: incidence of disabling stroke or neurological death (at 180 days and 1 year), incidence of in-stent thrombosis (at 180 days and 1 year), and incidence of in-stent stenosis (at 180 days and 1 year). Exploratory endpoints include stent wall apposition performance (intra-procedure), first-time deployment success rate (intra-procedure) and duration of stent deployment (intra-procedure).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 (or his/her legal representative) understands the nature of the procedure and provides voluntary written informed consent for the use of his/her peri-procedural and follow-up data;
- •Aged between 18 years and 80 years of age the time of consent;
- •Patient has been diagnosed with ruptured (Hunt-Hess Grade I-III) or unruptured intracranial aneurysm and requires the endovascular treatment;
- •Parent vessel with a diameter of ≥2.5 mm and ≤4 mm;
- •Patient is willing to return to the investigational site for the post-procedure follow-up evaluations.
排除标准
- •Severe co-morbidity associated with a life-expectancy of less than twelve months as determined by the investigator;
- •Poor clinical condition with modified Rankin Scale (mRS) score ≥4;
- •Having prior or potential severe allergic reaction to contrast medium;
- •Known allergies to any of the device components, including Enterprise 2 and PROWLER® SELECT™ Plus Infusion Catheter;
- •Angiogram demonstrating that the aneurysm is not appropriate for endovascular treatment (i.e. severe intracranial vessel tortuosity, stenosis, intracranial vasospasm not responsive to medical therapy);
- •Arteriovenous malformation (AVM) in the territory of the target aneurysm;
- •Unsuitable for the antithrombotic and/or anticoagulant therapies;
- •Implantation of an intracranial stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
- •Implantation of a carotid stent associated with aneurysm or symptom distribution within 12 weeks prior to signature of Informed Consent Form;
- •Evidence of active infection;
- •Pregnant or lactating women;
- •Having participated in clinical studies of other investigational drugs or devices within 30 days prior to signature of Informed Consent Form, excluding epidemiological studies of observational nature or natural history or not involving intervention;
- •Pre-planned staged procedure of target aneurysms.
研究组 & 干预措施
ENTERPRISE 2 group
The study population enrolled for this clinical study is "aneurysm patients who need stent-assisted coiling treatment", using ENTERPRISE 2 device.
干预措施: ENTERPRISE 2 device (Device)
结局指标
主要结局
Incidence of aneurysm recanalization
时间窗: at 180 days post procedure
Incidence of aneurysm recanalization (at 180 days) = number of target aneurysm recanalization (at 180 days) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 180-day follow-up will be obtained through DSA, and the post-procedure immediate aneurysm recanalization shown in angiograms will be graded as per the Raymond-Roy Classification Scale. The Raymond-Roy Classification at each follow-up time point increased by ≥ one class relative to that immediately after the procedure is defined as recanalization (e.g., Class I immediately after the procedure, Class II at 180-day follow-up).
次要结局
- Aneurysm occlusion(immediately post procedure, at 180 days and at 1 year post procedure)
- Incidence of aneurysm recanalization(at 1 year post procedure)
- Successful stent/coil placement rate(immediately post procedure)
- Incidence of retreatment(at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure)