Pipeline for Uncoilable or Failed Aneurysms

Study Overview
=================
Brief Summary
-----------------
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).

Detailed Description
-----------------
Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.

Official Title
-----------------
Pipeline for Uncoilable or Failed Aneurysms

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: Pipeline Embolization Device (PED)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 to 75 years, inclusive Patient has a single target IA in the anterior or posterior circulation that: a) Is located in the following regions of the internal carotid artery: i. Paraophthalmic (including paraclinoid, ophthalmic and hypophyseal segments) ii. Cavernous iii. Petrous b) Has a neck >4 mm or no discernible neck AND a size (maximum fundus diameter) >10 mm c) Has a parent vessel with diameter 2.5 - 5.0 mm distal/proximal to the target IA Subject has provided written informed consent using the Institutional Review Board (IRB)-approved consent form Subject has the necessary mental capacity to participate and is willing and able to comply with protocol requirements Exclusion Criteria: More than one IA requires treatment in the next 6 months Subarachnoid hemorrhage from target IA in the past 60 days Unstable neurologic deficit (i.e., any worsening of clinical condition in the last 30 days) 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 Stent in place at the target IA Contraindication to CT scan or MRI 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 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) 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 for anterior circulation aneurysms Intracranial stenosis greater than 50% in the treated vessel

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pipeline<br>Placement of Pipeline Embolization Device in the parent artery at the aneurysm location | Device: Pipeline Embolization Device (PED)<br>* 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. | The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years. | 180-days and 5-years | 
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis. | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year | The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 1 Year | 
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 3 years | 
| Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years | The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac | 5 years | 
| Stenosis of the Parent Artery in PED at 3 Years | Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up | 3-years | 
| Stenosis of the Parent Artery in PED at 5 Years | Parent artery stenosis at 5-year follow-up | 5-years | 
| Number of Participants With Device-Related Adverse Events at 3 Years | Number of participants with incidence of device-related adverse events at 3 year follow-up | 3 years | 
| Number of Participants With Device-related Adverse Events at 5 Years | Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement | 5 years | 

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