N/A
N=108
Pipeline for Uncoilable or Failed Aneurysms
Intracranial Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00777088 ↗Enrolled (actual)
108
Serious AEs
51.4%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. — 6; 10 Participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pipeline Embolization Device (PED) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. |
6; 10 | <.001 sig |
| PRIMARY Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis. |
78 | <0.001 sig |
| SECONDARY Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year |
79 | — |
| SECONDARY Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up |
71 | — |
| SECONDARY Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years |
59 | — |
| SECONDARY Stenosis of the Parent Artery in PED at 3 Years |
67; 8; 0; 3; 7 | — |
| SECONDARY Stenosis of the Parent Artery in PED at 5 Years |
50; 3; 1; 2; 8 | — |
| SECONDARY Number of Participants With Device-Related Adverse Events at 3 Years |
4 | — |
| SECONDARY Number of Participants With Device-related Adverse Events at 5 Years |
2 | — |
Summary
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).
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 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
Data sourced from ClinicalTrials.gov (NCT00777088). 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.