Pipeline for Uncoilable or Failed Aneurysms

Not Applicable

Completed

Conditions: Intracranial Aneurysm

Interventions: Device: Pipeline Embolization Device (PED)

Registration Number: NCT00777088

Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

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
Relative contraindication to angiography (e.g., serum creatinine > 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pipeline	Pipeline Embolization Device (PED)	Placement of Pipeline Embolization Device in the parent artery at the aneurysm location

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.	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.	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 Outcome Measures

Name	Time	Method
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year	1 Year	The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. 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
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up	3 years	The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. 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
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years	5 years	The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. 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
Stenosis of the Parent Artery in PED at 3 Years	3-years	Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up
Stenosis of the Parent Artery in PED at 5 Years	5-years	Parent artery stenosis at 5-year follow-up
Number of Participants With Device-Related Adverse Events at 3 Years	3 years	Number of participants with incidence of device-related adverse events at 3 year follow-up
Number of Participants With Device-related Adverse Events at 5 Years	5 years	Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement

Trial Locations

Locations (10): Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Stony Brook University
🇺🇸
Stony Brook, New York, United States
Rush University
🇺🇸
Chicago, Illinois, United States
Central Du Page Hospital
🇺🇸
Winfield, Illinois, United States
Washington University St. Louis
🇺🇸
Saint Louis, Missouri, United States
New York University
🇺🇸
New York, New York, United States
Barrow Neurological Institute
🇺🇸
Phoenix, Arizona, United States
Hacettepe University
🇹🇷
Ankara, Turkey
University of Buffalo
🇺🇸
Buffalo, New York, United States
National Institute of Neurosurgery
🇭🇺
Budapest, Hungary