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Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device

Intracranial Aneurysm Clinical Trial

Official title:
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 Wide-necked Saccular Intracranial Aneurysms

Clinical Trial Summary

The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.

Clinical Trial Description

The study is a prospective, multi-center, single arm, clinical study to evaluate the safety and effectiveness of the ENTERPRISE stent when used in conjunction with endovascular coil embolization in the treatment of unruptured wide-neck, intracranial, saccular anterior circulation aneurysms (≤ 10 mm). The primary objectives of the study are to evaluate the rate of complete angiographic occlusion at 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02532517
Study type Interventional
Source Cerenovus, Part of DePuy Synthes Products, Inc.
Contact
Status Terminated
Phase N/A
Start date September 1, 2015
Completion date September 21, 2019
View Details
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