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Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy (SHIELD)

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: NCT02719522
Recruitment Status : Completed
First Posted : March 25, 2016
Results First Posted : July 8, 2020
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Brief Summary:
This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: Pipeline™ Flex Embolization Device with Shield Technology™

Detailed Description:

Eligible subjects will be treated with the Pipeline™ Flex Embolization Device with Shield Technology™.

Subjects will undergo standard of care follow-up visits. Data generated per standard of care will be collected for 1 year beyond the index procedure.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402 (j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402 (j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

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Study Type : Observational
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)
Actual Study Start Date : March 2016
Actual Primary Completion Date : August 22, 2019
Actual Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Pipeline™ Flex Embolization Device with Shield Technology™

    Pipeline™ Flex Embolization Device with Shield Technology™ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technology™ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell.

    The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot.



Primary Outcome Measures :
  1. Safety - Stroke/Death Occurrence [ Time Frame: 1 year ]
    Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year)

  2. Effectiveness - Aneurysm Occlusion [ Time Frame: 1 year ]
    Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year)


Secondary Outcome Measures :
  1. Safety - Stroke/Death Occurrence - 30 Days [ Time Frame: 30 days ]
    Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications

  2. Safety - Intracerebral Hemorrhage (ICH) [ Time Frame: 1 year ]
    Percentage (%) of Participants who experienced a delayed intracerebral hemorrhage > 30 days post-procedure

  3. Effectiveness - Deployment Rate [ Time Frame: 1 year ]

    Percentage (%) of Participants who have had a successful deployment of the device at the target site.

    A device is considered properly deployed when it covers the entire length of the aneurysm neck.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have an intracranial aneurysm (IA). The Pipeline™ Flex Embolization Device with Shield Technology™ will be used according to its Instructions for Use and its intended use during the treatment regimen.
Criteria

Inclusion Criteria:

  • Subject has provided written Data Release Form (DRF) or informed consent using the Institutional Review Board (IRB)/ Ethic Committee (EC)-approved consent form and agrees to comply with protocol requirements.
  • At least 18 years of age.
  • Subject has already been selected for flow diversion therapy as the appropriate treatment.
  • Subject has a target IA that has a parent vessel with diameter 1.5-5.0 mm distal/proximal to the target IA.

Exclusion Criteria:

  • Major surgery including endovascular procedures within the past 30 days.
  • Subject with target IA located in the basilar artery
  • Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis determined from baseline or pre-procedure imaging, or a history of intracranial vasospasm not responsive to medical therapy.
  • Stent is in place in the parent artery at the target IA location.
  • Subject with an acutely (within 30 days) ruptured aneurysm with a Hunt and Hess grade of 4 or higher.
  • Any known contraindication to treatment with the Pipeline™ Flex Embolization Device with Shield Technology™ per Instructions for Use.
  • The investigator determines that the health of the subject or the validity of the study outcomes (e.g., high risk of neurologic events, conditions that may increase the chance of stroke, worsening of clinical condition in the last 30 days) may be compromised by the subject's enrollment.
  • Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.
  • Subject is currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from Medtronic.
  • Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures.

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): NCT02719522


Locations
Show Show 21 study locations
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Medtronic Bakken Research Center
Investigators
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Study Chair: Saleh Lamin The Queen Elizabeth Hospital
  Study Documents (Full-Text)

Documents provided by Medtronic Neurovascular Clinical Affairs:
Study Protocol  [PDF] June 24, 2016
Statistical Analysis Plan  [PDF] March 12, 2019

Publications:

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: NCT02719522    
Other Study ID Numbers: NV-PED-10
First Posted: March 25, 2016    Key Record Dates
Results First Posted: July 8, 2020
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be available

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Studies a U.S. FDA-regulated Drug Product: No
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