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

December 22, 2021 updated by: Medtronic Neurovascular Clinical Affairs

Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.)

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Southport, Australia, QLD 4215
        • Gold Coast University Hospital
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • Finland
      • Turku, Finland
        • Turun yliopistollinen keskussairaala
  • France
      • Le Kremlin-Bicêtre, France
        • Hôpital Bicêtre
  • Germany
      • Augsburg, Germany
        • Universitätsklinikum Augsburg
      • Berlin, Germany
        • Charité Centrum
      • Essen, Germany
        • Alfried Krupp Krankenhaus
      • Heidelberg, Germany
        • Universitätsklinikums Heidelberg
      • Homburg, Germany
        • Universitätsklinikum des Saarlandes
  • Greece
      • Athens, Greece
        • Hellenic Airforce Hospital
  • Hungary
      • Budapest, Hungary
        • Országos Klinikai Idegtudományi Intézet
  • Israel
      • Jerusalem, Israel
        • Hadassah Medical Organization
  • Italy
      • Cesena, Italy
        • Ospedale M. Bufalini
      • Milan, Italy
        • Istituto Neurologico Carlo Besta
  • Spain
      • Barakaldo, Spain
        • Hospital Universitario Cruces
      • Madrid, Spain
        • Hospital Universitario de la Princesa
      • Madrid, Spain, 28040
        • Hospital Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Universitario Puerta De Hierro
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Preston, United Kingdom
        • Royal Preston Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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)
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Collaborators

Medtronic Bakken Research Center

Investigators

  • Study Chair: Saleh Lamin, The Queen Elizabeth Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 22, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV-PED-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual participant data will be available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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