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

The procedure success rate is defined to be the percentage of aneurysms in which coil mass position is maintained within the sac with parent artery patency, without additional procedures for treatment of the aneurysm since the index procedure. The procedure success was summarized immediately post-treatment (acute), and at the 6- and 12-month follow-up assessments.

The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.

The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Complete/partial aneurysm occlusion is defined as an aneurysm in which a score of 1 (complete occlusion) or 2 (residual neck) is achieved on the Raymond Scale, regardless of retreatment. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month post-procedure follow-up visit was considered not to have achieved complete aneurysm occlusion.

Number of Participants with aneurysms occlusion of 100%, 90%-99%, 70-89%, 50-69%, 25-49%, or <25% occlusion in accordance with Consensus Grades 0 (100% complete aneurysm occlusion) - 5 (<25% volumetric aneurysm occlusion), respectively, was reported immediately post-procedure (acute), and at the 6 and 12 month follow-up, respectively.

Number of participants with aneurysm recanalization was reported. Recanalization was defined as an increase in aneurysm filling as compared to the previous study-specified angiographic assessment, resulting in a change in (that is, worsening of) the Raymond classification.

Retreatment was defined as any additional treatment of the target aneurysm after the index procedure (retreatment includes staged procedures), or an additional procedure (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture or bleeding.

Observed scores on the Modified Ranking Scale was presented at baseline (pre-procedure) and follow-up (30 days, 6 and 12 months post-procedure). mRS score: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities but able to look after own affairs without assistant; 3 = moderate disability, requires some help, but able to walk without assistance; 4 = moderate to severe disability, unable to walk without assistance, and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; 6 = dead. The number of participants who had an increase in mRS > 2 from baseline not related to stroke or death was also be presented for each follow-up time point.

The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of >= 4.

The percentage of target aneurysms in which a new occurrence of unintentional and persistent reduced TICI flow (TICI grade of 0: No perfusion or 1: Partial perfusion) was observed at the target vessel during the index procedure as a result of a mechanical obstruction such as dissection or luminal thrombus was evaluated. TICI evaluates perfusion severity and ranges from Grade 0 (No perfusion) to 3 (Complete perfusion).

The number of participants who experienced a procedure-related hemorrhagic event which required any of the following was evaluated: blood transfusion, surgical intervention, a new hospitalization, or lengthening of hospital stay. The complications of hematoma requiring treatment (that is, hematoma > 5 centimeter [cm] in diameter occurring at the access site) and retroperitoneal bleeding were reported as hemorrhagic events.

In-stent stenosis is defined as greater than 50% narrowing of the vessel within the ENTERPRISE stent or within 10 mm of either end of the stent.

Thrombosis is defined as in-stent thrombosis.