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Pipeline for Uncoilable or Failed Aneurysms (PUFS)

Primary Purpose

Intracranial Aneurysm

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pipeline Embolization Device (PED)
Sponsored by
Medtronic Neurovascular Clinical Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring neurovascular embolization, therapeutic embolization

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barrow Neurological Institute
  • Rush University
  • Central Du Page Hospital
  • Mayo Clinic
  • Washington University St. Louis
  • University of Buffalo
  • New York University
  • Stony Brook University
  • National Institute of Neurosurgery
  • Hacettepe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pipeline

Arm Description

Placement of Pipeline Embolization Device in the parent artery at the aneurysm location

Outcomes

Primary Outcome Measures

Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
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.
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

Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 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
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
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
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
Parent artery stenosis at 5-year follow-up
Number of Participants With Device-Related Adverse Events at 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
Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement

Full Information

First Posted
October 20, 2008
Last Updated
October 25, 2018
Sponsor
Medtronic Neurovascular Clinical Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00777088
Brief Title
Pipeline for Uncoilable or Failed Aneurysms
Acronym
PUFS
Official Title
Pipeline for Uncoilable or Failed Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
September 22, 2014 (Actual)
Study Completion Date
September 22, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Neurovascular Clinical Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
neurovascular embolization, therapeutic embolization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pipeline
Arm Type
Experimental
Arm Description
Placement of Pipeline Embolization Device in the parent artery at the aneurysm location
Intervention Type
Device
Intervention Name(s)
Pipeline Embolization Device (PED)
Intervention Description
1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Primary Outcome Measure Information:
Title
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
Description
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.
Time Frame
180-days and 5-years
Title
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
Description
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
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year
Description
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
Time Frame
1 Year
Title
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up
Description
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
Time Frame
3 years
Title
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years
Description
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
Time Frame
5 years
Title
Stenosis of the Parent Artery in PED at 3 Years
Description
Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up
Time Frame
3-years
Title
Stenosis of the Parent Artery in PED at 5 Years
Description
Parent artery stenosis at 5-year follow-up
Time Frame
5-years
Title
Number of Participants With Device-Related Adverse Events at 3 Years
Description
Number of participants with incidence of device-related adverse events at 3 year follow-up
Time Frame
3 years
Title
Number of Participants With Device-related Adverse Events at 5 Years
Description
Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tibor Bescke, MD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Central Du Page Hospital
City
Winfield
State/Province
Illinois
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Washington University St. Louis
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
Country
United States
Facility Name
National Institute of Neurosurgery
City
Budapest
Country
Hungary
Facility Name
Hacettepe University
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
27739944
Citation
Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
Results Reference
derived
PubMed Identifier
26162031
Citation
Sahlein DH, Fouladvand M, Becske T, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Kallmes DF, Nelson PK. Neuroophthalmological outcomes associated with use of the Pipeline Embolization Device: analysis of the PUFS trial results. J Neurosurg. 2015 Oct;123(4):897-905. doi: 10.3171/2014.12.JNS141777. Epub 2015 Jul 10.
Results Reference
derived

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Pipeline for Uncoilable or Failed Aneurysms

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