PREMIER NV-PED-07

Principal Investigator: Phil  Taussky
Keywords: Embolization , Intracranial , aneurysms , covidien , pipeline Department: Radiology Clinical
IRB Number: 00077491 Co Investigator:  
Specialty: Neurosurgery
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Salman  Yakub
salman.yakub@hsc.utah.edu
8015877462

Brief Summary

The primary study objective is to assess the safety (occurrence of major stroke in the territory supplied
by the treated artery or neurological death at 1 year post-procedure) and effectiveness (complete
aneurysm occlusion without significant parent artery stenosis at 1 year post-procedure) of the Pipeline™
device in the treatment of unruptured, wide-neck intracranial aneurysms , measuring ≤ 12 mm, located
in the internal carotid artery (up to the terminus) or the vertebral artery segment up to and including
the posterior inferior cerebellar artery.
Primary Endpoints

• Safety: Occurrence of major stroke in the territory supplied by the treated artery or
neurological death at 1 year post-procedure
• Effectiveness: Complete aneurysm occlusion (defined by scale of Roy) without significant
parent artery stenosis (≤ 50%) at 1 year post-procedure

Secondary Endpoints
• Safety
    o Occurrence of major stroke in the territory supplied by the treated artery or
neurological death at 30 days post-procedure due to procedural complications
   o Delayed intracerebral hemorrhage >30 days post-procedure
• Effectiveness: Device deployment success rate at the target site

 

 

 
 
 
 
 

Inclusion Criteria

1. Subject has provided written informed consent using the IRB/EC-approved consent form
and agrees to comply with protocol requirements.
2. Age 22-80 years.
3. Subject has a target intracranial aneurysm (IA) located in the:
a. Internal carotid artery (up to the carotid terminus) OR
b. Vertebral artery segment up to and including the posterior inferior cerebellar artery
4. Subject has a target IA that is ≤ 12 mm.
5. Subject has a target IA that has a parent vessel with diameter 1.5–5.0 mm distal/proximal
to the target IA.
6. Subject has a target IA with an aneurysm neck ≥ 4mm or a dome to neck ratio ≤ 1.5.
7. Subject has a pre-procedure PRU value between 60–200.

Exclusion Criteria

1. Subject has received an intracranial implant (e.g. coils) in the area of the target IA within
the past 12 weeks.
2. Subarachnoid hemorrhage in the past 30 days.
3. 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.
4. Major surgery in the last 30 days.
5. History of irreversible bleeding disorder and/or subject presents with signs of active
bleeding.
6. Any known contraindication to treatment with the Pipeline™ device, including:
a. Stent is in place in the parent artery at the target IA location
b. Contraindication to dual antiplatelet therapy
c. Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy
to contrast that cannot be medically controlled).
d. Known severe allergy to platinum or cobalt/chromium alloys.
e. Evidence of active infection at the time of treatment (e.g., fever with temperature
>38°C and/or WBC >1.5 109/L).
7. 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.
8. Pregnant or breast-feeding women or women who wish to become pregnant during the
length of study participation.
9. Participating in another clinical trial during the follow-up period that could confound the
treatment or outcomes of this investigation.
Before any subject is enrolled in the study, the baseline angiogram will be reviewed by a Pipeline™
device expert to ensure that the target IA is amenable to treatment with the Pipeline™ device.