Pipeline for Uncoilable or Failed Aneurysms (PUFS)
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ClinicalTrials.gov Identifier: NCT00777088 |
Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : September 11, 2018
Last Update Posted : November 20, 2018
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Condition or disease | Intervention/treatment | Phase |
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Intracranial Aneurysm | Device: Pipeline Embolization Device (PED) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Pipeline for Uncoilable or Failed Aneurysms |
Actual Study Start Date : | October 2008 |
Actual Primary Completion Date : | September 22, 2014 |
Actual Study Completion Date : | September 22, 2014 |

Arm | Intervention/treatment |
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Experimental: Pipeline
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
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Device: Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach |
- 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
- Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5-years ]Parent artery stenosis at 5-year follow-up
- Number of Participants With Device-Related Adverse Events at 3 Years [ Time Frame: 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 [ Time Frame: 5 years ]Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement

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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 21 to 75 years, inclusive
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777088
United States, Arizona | |
Barrow Neurological Institute | |
Phoenix, Arizona, United States, 85013 | |
United States, Illinois | |
Rush University | |
Chicago, Illinois, United States | |
Central Du Page Hospital | |
Winfield, Illinois, United States | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States | |
United States, Missouri | |
Washington University St. Louis | |
Saint Louis, Missouri, United States | |
United States, New York | |
University of Buffalo | |
Buffalo, New York, United States | |
New York University | |
New York, New York, United States | |
Stony Brook University | |
Stony Brook, New York, United States | |
Hungary | |
National Institute of Neurosurgery | |
Budapest, Hungary | |
Turkey | |
Hacettepe University | |
Ankara, Turkey |
Principal Investigator: | Tibor Bescke, MD | New York University |
Responsible Party: | Medtronic Neurovascular Clinical Affairs |
ClinicalTrials.gov Identifier: | NCT00777088 |
Other Study ID Numbers: |
COVPUFS0398 |
First Posted: | October 22, 2008 Key Record Dates |
Results First Posted: | September 11, 2018 |
Last Update Posted: | November 20, 2018 |
Last Verified: | October 2018 |
neurovascular embolization therapeutic embolization |
Intracranial Aneurysm Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |