NCT02532517

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cerenovus, Part of DePuy Synthes Products, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-01-08
• Completion: 2019-09-21
• First posted: 2015-08-25
• Last updated: 2020-10-23
• Results posted: 2020-10-23

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study