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

Cerenovus

Status

Terminated

Conditions

Intracranial Aneurysm

Treatments

Device: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02532517

NV-IDE-1001

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

21 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm
Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment
Subject is willing to comply with specified follow-up evaluation

Exclusion criteria

Planned staged procedure
Currently enrolled in another investigational device or drug study
Target aneurysm that has been previously treated
Mycotic, fusiform or dissecting aneurysm
Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0
A serum creatinine level > 2.5 mg/dL within 7 days prior to index procedure