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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 45
- Locations
- 11
- Primary Endpoint
- Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory
Study Overview
Brief Summary
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Enterprise
Intervention: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System (Device)
Outcomes
Primary Outcomes
Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory
Time Frame: At 12 Months post procedure
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.
Percentage of Participants With Complete Aneurysm Occlusion (RCAO) Without Retreatment at 12-Month Post Procedure
Time Frame: 12 Months 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.
Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure
Time Frame: 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.
Secondary Outcomes
- Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score(Post-procedure up to 30-Day, 6-Month Follow-up and 12-Month Follow-up)
- Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months(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(Immediately post-procedure (acute), 6 and 12 months)
- Number of Participants With Aneurysm Recanalization(Up to 12 months)
- Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months(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(Immediately post-procedure (acute), 6 and 12 Months)
- Number of Participants With Reduced Thrombolysis in Cerebral Infarction (TICI) Flow (New Occurrence of TICI Grade of 0 or 1)(Day 1 (Intraoperative))
- Number of Participants With Bleeding Complications(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(During procedure (acute), post-procedure up to 6 months and 12 months follow up)
- Number of Participants Retreated With Any Additional Treatment(Up to 12 months)
- Number of Participants With NIH Stroke Scale (NIHSS) Worsening(Post-procedure up to 6-Month and 12-Month Follow-up)
- Number of Participants With Thrombosis Per Independent Core Laboratory(During procedure (acute), post-procedure up to 6 months and 12 months follow up)