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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 : Active, not recruiting
First Posted : March 25, 2016
Last Update Posted : January 28, 2019
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.


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Study Type : Observational
Estimated Enrollment : 200 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)
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 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. Rate of stroke/neurologic death occurred at 1 year [ Time Frame: 1 year ]


Information from the National Library of Medicine

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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. 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.

Exclusion Criteria:

  • Major surgery including endovascular procedures within the past 30 days.
  • Subject with anatomy not appropriate for endovascular treatment.
  • Stent is in place in the parent artery at the target IA location.
  • 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.
  • 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
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Australia
Gold Coast University Hospital
Southport, Australia, QLD 4215
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Spain
Hospital Fundación Jiménez Díaz
Madrid, Spain, 28040
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Medtronic Bakken Research Center
Investigators
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Study Chair: Saleh Lamin Queen Elizabeth Hospital

Publications:

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02719522     History of Changes
Other Study ID Numbers: NV-PED-10
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases