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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
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordis Self Expanding Stent | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Successful stent placement with satisfactory coil mass position angiographically. | immediately after post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edoardo Boccardi, MD | Azienda Ospedaliera | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera | Milan | 20162 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16091525 | Background | 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. | |
| 17476494 | Result | Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kuhne 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):555-61. doi: 10.1007/s00234-007-0232-2. Epub 2007 May 3. |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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