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

Medtronic

Status: Completed

Conditions: Intracranial Aneurysm

Treatments: Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02186561

NV-PED-07

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

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:

   1. Internal carotid artery (up to the carotid terminus) OR
   2. 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:

   1. Stent is in place in the parent artery at the target IA location
   2. Contraindication to dual antiplatelet therapy
   3. Relative contraindication to angiography (e.g., serum creatinine >2.5 mg/dL, allergy to contrast that cannot be medically controlled).
   4. Known severe allergy to platinum or cobalt/chromium alloys.
   5. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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197 participants in 1 patient group

Pipeline™ Embolization Device

Experimental group

Description:

treatment with Pipeline™ Embolization Device

Treatment:

Device: Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device