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.
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).
Study Type
OBSERVATIONAL
Enrollment
164
The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Incidence of aneurysm recanalization
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).
Time frame: at 180 days post procedure
Incidence of aneurysm recanalization
Incidence of aneurysm recanalization (at 1 year) = number of target aneurysm recanalization (at 1 year) ÷ total number of target aneurysms receiving follow-up × 100%. The results of aneurysm angiography at 1 year follow-ups will be obtained through DSA or MRA or CTA.
Time frame: at 1 year post procedure
Successful stent/coil placement rate
Successful stent/coil placement rate = number of target aneurysms with successful stent/coil placement ÷ total number of target aneurysms× 100%. Successful stent/coil placement is defined as successful stent deployment and successful delivery and placement of the coil at the target aneurysm assessed immediately post procedure through angiography.
Time frame: immediately post procedure
Aneurysm occlusion
Aneurysm occlusion rate = number of target aneurysms with Raymond-Roy Class I or II aneurysm occlusion÷ total number of target aneurysms× 100%. The aneurysm occlusion will be assessed by classifying the post-procedure immediate aneurysm occlusion shown in angiograms based on the Raymond-Roy Classification.
Time frame: immediately post procedure, at 180 days and at 1 year post procedure
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The first affiliated hospital of Zhengzhou university
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
The first affiliated hospital of Nanchang university
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Huashan Hospital Shanghai Medical college, Fudan University
Shanghai, Shanghai Municipality, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
Incidence of retreatment
Incidence of retreatment = number of target aneurysms receiving retreatment during the follow-up ÷ total number of target aneurysms receiving follow-up ×100%. Retreatment refers to any intervention to the target aneurysm after completing first stent-assisted coil embolization for the target aneurysm.
Time frame: at 30 days, 180 days, 1 year, 2 years, 3 years, 4 years and 5 years post procedure