Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

Official Title
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Prospective Study on Embolization of Intracranial Aneurysms With the Pipeline™ Device (PREMIER)

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements. Age 22-80 years. Subject has a target intracranial aneurysm (IA) located in the: Internal carotid artery (up to the carotid terminus) OR Vertebral artery segment up to and including the posterior inferior cerebellar artery Subject has a target IA that is ≤ 12 mm. Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5. Subject has a pre-procedure PRU value between 60-200. Exclusion Criteria: Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks. Subarachnoid hemorrhage in the past 30 days. Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy. Major surgery in the last 30 days. History of irreversible bleeding disorder and/or subject presents with signs of active bleeding. Any known contraindication to treatment with the Pipeline™ device, including: Stent is in place in the parent artery at the target IA location Contraindication to dual antiplatelet therapy Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy to contrast that cannot be medically controlled). Known severe allergy to platinum or cobalt/chromium alloys. Evidence of active infection at the time of treatment (e.g., fever with temperature >38°C and/or WBC >1.5 109/L). The Investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 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: Pipeline™ Embolization Device<br>treatment with Pipeline™ Embolization Device | Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants With the Occurrence of Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 12-Months Post Procedure | The primary safety endpoint was defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Missing data for subjects who failed to complete the 12- month post-procedure evaluation without any evidence of a major stroke in the territory supplied by the treated artery or neurological death were imputed in the analysis using multiple imputation. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination. | Up to 12 Months Post Procedure | 
| The Percentage of Participants With Complete Aneurysm Occlusion (Defined as Raymond Roy Grade 1) Without Significant Parent Artery Stenosis (≤ 50%) or Retreatment of the Target Aneurysm at 12-Months Post-Procedure | The definitions for the three components of the primary effectiveness endpoint were: 1) retreatment, defined as all retreatment procedures occurring between the index procedure and 1 Year post-procedure; 2) complete aneurysm occlusion based on Core Laboratory review of 1-year images and 3) significant parent artery stenosis, based on Core Laboratory review of 1-year images. The Raymond-Roy Grading scale is used for judging intracranial aneurysm (IA) endosaccular embolization success. 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. Multiple imputation provides a mechanism for deriving estimates for a population where not all of the patients have an endpoint determination. | Up to 12 Months Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants With a Major Stroke in the Territory Supplied by the Treated Artery or Neurological Death at 30-days Post Procedure Due to Procedural Complications | Major Stroke is defined as a stroke which results in focal neurological deficit for 24 hrs or more and increases the NIH Stroke Scale of the subject by ≥ 4 along with an imaging correlate. Neurological death is any subject death due to neurologic reasons. | Up to 30 days, Post Procedure | 
| The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure | For the purpose of this protocol, delayed intracerebral hemorrhage was defined as hemorrhage within the fixed vault of the cranium (skull) occurring greater than 30 days post-procedure. | > 30 days, Post Procedure | 
| The Number of Participants With Successfully Deployed Investigational Device | The secondary outcome measures provides the number of participants successfully implanted with the Investigational device during the study index procedure at the target site. | Index Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial aneurysm, brain aneurysm