Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Cerus Endovascular, Ltd
- Enrollment
- 34
- Locations
- 6
- Primary Endpoint
- Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour").
The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.
Detailed Description
Contour Neurovascular System™ European Pre-Market Unruptured Aneurysm Study (CERUS) initiated enrollment in October 2018 to assess the safety and effectiveness of the Contour Neurovascular System ("Contour") in treatment of intracranial aneurysms (IA) with the intended indication for endovascular embolization of saccular IA. This prospective, single-arm, multicenter study was conducted to document the safety and performance of the Contour in treatment for patients with an IA.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Safety Endpoint: Percentage of Participants With Death of Any Non-accidental Cause or Major Disabling Stroke Within First 30 Days After Treatment or Major Disabling Stroke or Death Due to Neurological Cause From Day 31 to 6 Months After Treatment.
Time Frame: 6 months
The Primary Safety Endpoint is the percentage of subjects with death of any non-accidental cause or any major disabling stroke within the first 30 days after treatment or major disabling stroke or death due to neurological cause from day 31 to 6 months after treatment. Major Disabling Stroke is defined as an episode of neurological signs or symptoms that persist beyond 24 hours accompanied with evidence of ischemia/infarction on imaging that results in an increase of NIHSS from baseline by \>= 4 points and/or an increase from mRS baseline by \>2. An independent Clinical Events Committee adjudicated all data used for safety endpoint analyses.
Primary Performance Endpoint: Percentage of Subjects With Complete Aneurysm Occlusion at 6 Months.
Time Frame: 6 months
The Primary Performance Endpoint was the percentage of subjects with complete aneurysm occlusion at 6 months as adjudicated by an independent core laboratory. Occlusion was assessed using the Raymond-Roy occlusion scale (Class 1 - Complete occlusion; Class 2 - Residual neck; Class 3 - Residual aneurysm).