Ignite Creation Date:
2024-05-06 @ 2:19 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04289480
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2020-02-27
Brief Title:
Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
Sponsor:
Medos International SARL
Organization:
Medos International SARL
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
Brief 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
Detailed 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 25 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 stentcoil 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
The study population will consist of 164 patients with ruptured or unruptured intracranial aneurysms and a parent vessel diameter of 25 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 stentcoil 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None