Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the morbidity, mortality, and efficacy of use of the Enterprise(TM) stent for the treatment of (ruptured or non-ruptured) intracranial aneurysms.
Per the opinion of the Commission for the Evaluation of Products and Services (CEPP) in France, renewal is contingent upon setup of a prospective morbidity, mortality, and efficacy study. The objective is to follow the stented Subjects for at least 1 year and evaluate the device and practices.
This will be a multicenter study involving up to 15 interventional neuroradiologists in France. Subjects presenting with ruptured or non-ruptured aneurysms for whom simple or balloon assisted endovascular treatment is considered impossible or insufficient by the interventional neuroradiologist.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-ruptured aneurysms | Patients with intracranial aneurysm(s) requiring an endovascular treatment with a Codman ENTERPRISE stent who have one or more non-ruptured or late ruptured (>30days), intracranial aneurysm. | ||
| Acute ruptured Aneurysms | Patients with intracranial aneurysm(s) requiring an endovascular treatment with a Codman ENTERPRISE stent who have a on or more acute ruptured (<30Days) aneurysms |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and Mortality | Day 30 and 1 year post-procedure |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects presenting with ruptured or non-ruptured aneurysms for whom simple or balloon-assisted endovascular treatment is considered impossible or insufficient by the interventional neuroradiologist.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Megerian, MD, PhD | Codman & Shurtleff | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France | |||
| Jean Minjoz Hospital |
Not provided
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Besançon |
| 25030 |
| France |
| Pellegrin Hospital | Bordeaux | 33076 | France |
| Albert Michallon Hospital | Grenoble | 38043 | France |
| Roger Salengro Hospital | Lille | 59037 | France |
| Timone Hospital | Marseille | 13005 | France |
| Lariboisiere Hospital | Paris | 75010 | France |
| La Pitie Salpetiere Hospital | Paris | 75561 | France |
| Pitie Salpetriere Hospital | Paris | 75561 | France |
| La Pitie Salpetriere Hospital | Paris | 75651 | France |
| Rothschild Foundation | Paris | 75940 | France |
| Beaujon Hospital | Paris | 92118 | France |
| White House Hospital | Reims | 51092 | France |
| Purpan Hospital | Toulouse | 31059 | France |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |