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Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms — EMPOWER  

Intracranial Aneurysm Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04289480
Study type Observational
Source Medos International SARL
Contact
Status Active, not recruiting
Phase
Start date July 30, 2020
Completion date January 26, 2027
View Details
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