Clinical trial NCT02390037: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Official title: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2015-03-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neuroradiologists and surgeons practice

Brief summary: The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.


Eligibility criteria: Inclusion Criteria:

1. Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements.
2. Age 18-80 years.
3. Subject has already been selected for flow diversion therapy as the appropriate treatment.
4. Subject has an unruptured target intracranial aneurysm (IA).
5. Subject has a target IA located in the anterior or posterior circulation.

Exclusion Criteria:

1. Major surgery in the past 30 days.
2. Any known contraindication to treatment with the Pipeline™ Flex embolization device with Shield Technology™ per Instructions for Use.
3. Pregnant or breast-feeding women or women who wish to become pregnant during the length of study participation.

Primary outcomes:
measure: Occurrence of major stroke or neurological death
timeFrame: 1 year
Secondary outcomes:
measure: Device related neurologic adverse event rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Koln
country: Germany
facility: Uniklinik Koln
city: Athens
country: Greece
facility: Hellenic Air Force Hospital
city: Milan
country: Italy
facility: IRCCS Fondazione Istituto Neurologico C Besta
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital Birmingham
Study officials:
affiliation: Ospedale Niguarda "Ca' Granda"
name: Edoardo Boccardi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Galdamez M, Lamin SM, Lagios KG, Liebig T, Ciceri EF, Chapot R, Stockx L, Chavda S, Kabbasch C, Farago G, Nordmeyer H, Boulanger T, Piano M, Boccardi EP. Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up. J Neurointerv Surg. 2019 Apr;11(4):396-399. doi: 10.1136/neurintsurg-2018-014204. Epub 2018 Sep 27.
citation: Martinez-Galdamez M, Lamin SM, Lagios KG, Liebig T, Ciceri EF, Chapot R, Stockx L, Chavda S, Kabbasch C, Farago G, Nordmeyer H, Boulanger T, Piano M, Boccardi EP. Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study. J Neurointerv Surg. 2017 Aug;9(8):772-776. doi: 10.1136/neurintsurg-2016-012896. Epub 2017 Feb 20.