The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

Codman & Shurtleff

Status and phase: Completed; Phase 1

Conditions: Aneurysms

Treatments: Device: Cordis Self Expanding Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00288405

EN-03-01

Details and patient eligibility

About

To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Full description

This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Enrollment: 31 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with intracranial, wide-neck, saccular aneurysms

Exclusion criteria

• Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)