N/A
N=197
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
Intracranial Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT02186561 ↗Enrolled (actual)
197
Serious AEs
35.0%
Results posted
May 2019
Primary outcome: Primary: 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 — 2.17 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
2.17 | — |
| PRIMARY 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 |
76.71 | — |
| SECONDARY 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 |
— | — |
| SECONDARY The Number of Participants Who Experienced Delayed Intracerebral Hemorrhage > 30 Days Post-Procedure |
1 | — |
| SECONDARY The Number of Participants With Successfully Deployed Investigational Device |
140 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02186561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.