Clinical trial NCT02719522: Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy
Official title: Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy of Treated Intra Cranial Aneurysms (SHIELD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2016-03-25
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.)

Eligibility 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.

Primary outcomes:
measure: Safety - Stroke/Death Occurrence
timeFrame: 1 year
measure: Effectiveness - Aneurysm Occlusion
timeFrame: 1 year
Secondary outcomes:
measure: Safety - Stroke/Death Occurrence - 30 Days
timeFrame: 30 days
measure: Safety - Intracerebral Hemorrhage (ICH)
timeFrame: 1 year
measure: Effectiveness - Deployment Rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Turku
country: Finland
facility: Turun Yliopistollinen keskussairaala
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre
city: Augsburg
country: Germany
facility: Universitätsklinikum Augsburg
city: Berlin
country: Germany
facility: Charité Centrum
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Heidelberg
country: Germany
facility: Universitätsklinikums Heidelberg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Athens
country: Greece
facility: Hellenic Airforce Hospital
city: Budapest
country: Hungary
facility: Országos Klinikai Idegtudományi Intézet
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Cesena
country: Italy
facility: Ospedale M. Bufalini
city: Milan
country: Italy
facility: Istituto Neurologico Carlo Besta
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Saleh Lamin
role: STUDY_CHAIR
References:
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citation: Skukalek SL, Winkler AM, Kang J, Dion JE, Cawley CM, Webb A, Dannenbaum MJ, Schuette AJ, Asbury B, Tong FC. Effect of antiplatelet therapy and platelet function testing on hemorrhagic and thrombotic complications in patients with cerebral aneurysms treated with the pipeline embolization device: a review and meta-analysis. J Neurointerv Surg. 2016 Jan;8(1):58-65. doi: 10.1136/neurintsurg-2014-011145. Epub 2014 Nov 10.
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