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

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.

Detailed Description
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The study is a prospective, multi-center, single arm, clinical study to evaluate the safety and effectiveness of the ENTERPRISE stent when used in conjunction with endovascular coil embolization in the treatment of unruptured wide-neck, intracranial, saccular anterior circulation aneurysms (≤ 10 mm). The primary objectives of the study are to evaluate the rate of complete angiographic occlusion at 12 months.

Official Title
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A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System When Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-necked Saccular Intracranial Aneurysms

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment Subject is willing to comply with specified follow-up evaluation Exclusion Criteria: Planned staged procedure Currently enrolled in another investigational device or drug study Target aneurysm that has been previously treated Mycotic, fusiform or dissecting aneurysm Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0 A serum creatinine level > 2.5 mg/dL within 7 days prior to index procedure

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enterprise<br> | Device: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Complete Aneurysm Occlusion (RCAO) Without Retreatment at 12-Month Post Procedure | 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 were retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion. | 12 Months Post Procedure | 
| Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure | The incidence of a major ipsilateral stroke and/or death due to ipsilateral stroke was evaluated from the start of the index procedure until completion of the 12-month follow-up. A major ipsilateral stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of greater than or equal to (>=) 4 on the National Institute of Health Stroke Scale (NIHSS) as compared to baseline and persists for greater than 24 hours. The 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. | At 12 Months Post Procedure | 
| Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory | In-stent stenosis is defined as greater than 50 percent (%) narrowing of the vessel within the ENTERPRISE stent or within 10 millimeters (mm) of either end of the stent. | At 12 Months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months | 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. | Immediately post-procedure (acute), 6 and 12 months | 
| Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months | 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. | Immediately post-procedure (acute), 6 and 12 months | 
| Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months | 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. | Immediately post-procedure (acute), 6 and 12 Months | 
| Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months | 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. | Immediately post-procedure (acute), 6 and 12 months | 
| Number of Participants With Aneurysm Recanalization | 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. | Up to 12 months | 
| Number of Participants Retreated With Any Additional Treatment | 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. | Up to 12 months | 
| Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score | 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. | Post-procedure up to 30-Day, 6-Month Follow-up and 12-Month Follow-up | 
| Number of Participants With NIH Stroke Scale (NIHSS) Worsening | 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. | Post-procedure up to 6-Month and 12-Month Follow-up | 
| Number of Participants With Reduced Thrombolysis in Cerebral Infarction (TICI) Flow (New Occurrence of TICI Grade of 0 or 1) | 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). | Day 1 (Intraoperative) | 
| Number of Participants With Bleeding Complications | 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. | 12 months | 
| Number of Participants With In-Stent Stenosis Per Independent Core Laboratory During Procedure (Acute), Post-procedure up to 6 Months and 12 Months Follow up | 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. | During procedure (acute), post-procedure up to 6 months and 12 months follow up | 
| Number of Participants With Thrombosis Per Independent Core Laboratory | Thrombosis is defined as in-stent thrombosis. | During procedure (acute), post-procedure up to 6 months and 12 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CODMAN ENTERPRISE® Vascular Reconstruction Device, Wide Neck, Intracranial, Saccular Aneurysms, Cerebral Aneurysms