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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
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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Brief Summary:
To determine the safety and effectiveness of Pipeline Embolization Device for the treatment of uncoilable or failed wide-necked intracranial aneurysms (IA).

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Pipeline Embolization Device (PED) Not Applicable

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.
Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pipeline
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
 Device: Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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 Outcome Measures :
  1. 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


  2. 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


  3. 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


  4. 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

  5. Stenosis of the Parent Artery in PED at 5 Years [ Time Frame: 5-years ]
    Parent artery stenosis at 5-year follow-up

  6. 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

  7. 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


Eligibility Criteria
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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
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
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Principal Investigator: Tibor Bescke, MD New York University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Medtronic Neurovascular Clinical Affairs:
neurovascular embolization
therapeutic embolization
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases