Enterprise IDE: A Prospective, Multi-Center, Single Arm Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System When Used in Conjunction with Endovascular Coil Embolization in the Treatment of the Wide-necked Saccular Intracranial Aneurysms
ID Number 16-1803Principal Investigator(s)
Reade A De Leacy
Department(s) or Division(s)
The purpose of this prospective, multi-center, single arm research study is to evaluate the safety and effectiveness of the CODMAN ENTERPRISE® and ENTERPRISE® 2 for endovascular (through the blood vessels) stent-assisted coil embolization (blocking off blood flow) of intracranial (in the brain) wide-neck aneurysms (a ballooning out of the artery). This study is being conducted to determine whether stenting the aneurysm with ENTERPRISE® or ENTERPRISE® 2 works well. If the data is conclusive, it will be used to support an application to the Food and Drug Administration (FDA) to obtain full approval of ENTERPRISE® and ENTERPRISE® 2.
Recruiting Patients: Yes