Aneurysms Clinical Trial
Official title:
Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
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
Status | Completed |
Enrollment | 31 |
Est. completion date | December 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: - Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera | Milano |
Lead Sponsor | Collaborator |
---|---|
Codman & Shurtleff |
Italy,
Higashida RT, Halbach VV, Dowd CF, Juravsky L, Meagher S. Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: the Cordis Enterprise stent. AJNR Am J Neuroradiol. 2005 Aug;26(7):1751-6. — View Citation
Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kühne D. A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms. Neuroradiology. 2007 Jul;49(7 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful stent placement with satisfactory coil mass position angiographically. | immediately after post procedure |
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