NCT03680742

Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Cerus Endovascular, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Contour Neurovascular System	The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.

Timeline

• Start date: 2018-09-18
• Primary completion: 2020-08-10
• Completion: 2021-02-02
• First posted: 2018-09-21
• Last updated: 2021-06-23
• Results posted: 2021-05-24

Locations

6 sites across 3 countries: Austria, Denmark, Germany