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Pipeline for Uncoilable or Failed Aneurysms (PUFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 20, 2008
First Posted Date  ICMJE October 22, 2008
Results First Submitted Date  ICMJE March 7, 2018
Results First Posted Date  ICMJE September 11, 2018
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE October 2008
Actual Primary Completion Date September 22, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pipeline for Uncoilable or Failed Aneurysms
Official Title  ICMJE Pipeline for Uncoilable or Failed Aneurysms
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intracranial Aneurysm
Intervention  ICMJE Device: Pipeline Embolization Device (PED)
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Study Arms  ICMJE Experimental: Pipeline
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
Intervention: Device: Pipeline Embolization Device (PED)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2018)
108
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 22, 2014
Actual Primary Completion Date September 22, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00777088
Other Study ID Numbers  ICMJE COVPUFS0398
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Neurovascular Clinical Affairs
Study Sponsor  ICMJE Medtronic Neurovascular Clinical Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tibor Bescke, MD New York University
PRS Account Medtronic Neurovascular Clinical Affairs
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP