Pipeline for Uncoilable or Failed Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Enrollment
- 108
- Locations
- 10
- Primary Endpoint
- Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).
Detailed Description
Patients with large or giant aneurysms of the internal carotid artery treated with PED. Angiographic follow-up occurs at 3 and 5 years.
Investigators
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 \< 100 x 103 cells/mm3 or known platelet dysfunction
- •Inability to tolerate, documented evidence of adverse reaction or contraindication to study medications
- •Stent in place at the target IA
- •Contraindication to CT scan or MRI
- •Allergy to contrast used in angiography that cannot be medically controlled
- •Known severe allergy to platinum or cobalt/chromium alloys
Outcomes
Primary Outcomes
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
Time Frame: 180-days and 5-years
The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
Time Frame: 180 days
The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac
Secondary Outcomes
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year(1 Year)
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up(3 years)
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years(5 years)
- Stenosis of the Parent Artery in PED at 3 Years(3-years)
- Stenosis of the Parent Artery in PED at 5 Years(5-years)
- Number of Participants With Device-Related Adverse Events at 3 Years(3 years)
- Number of Participants With Device-related Adverse Events at 5 Years(5 years)