Complete Occlusion of Coilable Aneurysms

Study Overview
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Brief Summary
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To compare the safety and effectiveness of Pipeline Embolization Device to coil embolization for the treatment of coilable wide-necked intracranial aneurysms

Official Title
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Complete Occlusion of Coilable Aneurysms

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Pipeline Embolization Device (PED)
* Device: Coil embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 to 75 years, inclusive Patient has a single target IA that: is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous is saccular has a parent vessel with diameter 2.5-5.0 mm If target IA has a neck >4 mm, at least 2 of 3 members of an independent expert committee (IEC) have confirmed that coil embolization with optional adjunctive techniques** has a very high likelihood of procedural success (i.e., coil placement and retention) Subject has provided written informed consent using the IRB-approved consent form Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements ** Adjunctive techniques include intravascular balloons [balloon remodeling], 3D coils, dual catheter techniques. Exclusion Criteria: Target IA has BOTH neck >4 mm AND size (maximum fundus diameter) >10 mm More than one IA requires treatment in the next 6 months Subarachnoid hemorrhage in the past 60 days Any intracranial hemorrhage in the last 42 days Major surgery in the last 42 days Coils in place in the target IA Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days) Known irreversible bleeding disorder Platelet count < 100 x 103 cells/mm3 or known platelet dysfunction Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications Prior stent placement at target site Contraindication to CT scan AND MRI Known allergy to contrast used in angiography that cannot be medically controlled Known severe allergy to platinum or cobalt/chromium alloys Relative contraindication to angiography (e.g., serum creatinine > 2.5 mg/dL) Woman of child-bearing potential who cannot provide a negative pregnancy test Evidence of active infection at the time of treatment Other known conditions of the heart, blood, brain or intracranial vessels that carry a high risk of neurologic events (e.g., severe heart failure, atrial fibrillation, known carotid stenosis) Current use of cocaine or other illicit substance Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments to 180 days Extracranial stenosis greater than 50% in the carotid artery Intracranial stenosis greater than 50% in the treated vessel

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coil embolization<br>Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed. Stents are not allowed in this arm. | Device: Coil embolization<br>* Placement of bare platinum coils into the target aneurysm with balloon remodeling allowed.<br>|
| Experimental: Pipeline<br>Placement of 1 or more Pipeline Embolization Device(s)(PED) into the parent artery at the target aneurysm. | Device: Pipeline Embolization Device (PED)<br>* 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach.<br>* Other names: Pipeline Embolization Device, PED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness: Proportion of subjects whose target aneurysm shows complete occlusion on angiogram with <=50% stenosis of the parent artery. Safety: Proportion of subjects with ipsilateral major stroke or neurologic death. |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete target aneurysm occlusion |  | 1, 3 and 5 years | 
| Incidence of ipsilateral major stroke |  | 180 days | 
| Change in modified Rankin scale (MRS) |  | 180 days, 1, 3 and 5 years | 
| Incidence of device-related adverse events |  | 180 days, 1, 3 and 5 years | 
| Change from baseline in neurologic signs or symptoms related to the target aneurysm |  | 180 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurovascular embolization, therapeutic embolization