Contour Neurovascular System - European Pre-Market Unruptured Aneurysm (CERUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03680742|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2018
Last Update Posted : October 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysm||Device: Contour Neurovascular System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Contour Neurovascular System - European Pre-Market Unruptured Aneurysm Study (CERUS)|
|Actual Study Start Date :||September 18, 2018|
|Actual Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||November 1, 2020|
- Device: Contour Neurovascular System
The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
- Primary Safety Endpoint; The proportion 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. [ Time Frame: From day 31 to 6 months after treatment ]The proportion 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.
- Primary Performance Endpoint; To demonstrate the occlusion rate on the 6 month angiogram [ Time Frame: 6 months after treatment ]To demonstrate the occlusion rate on the 6 month angiogram as adjudicated by a core laboratory. Success will be defined as complete occlusion demonstrated by a Grade 1 using the Raymond Roy Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680742
|Salzburg, Austria, 5020|
|Odense University Hospital|
|Augsburg, Germany, 86156|
|UKSH Campus Kiel|
|UKSH Campus Luebeck|
|Klinikum der Universitat München|
|Munich, Germany, 81377|
|Principal Investigator:||Thomas Liebig, MD||Ludwig-Maximilians - University of Munich|