NCT02390037

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™.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
6 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

March 6, 2015

Last Update Submit

January 31, 2019

Conditions

Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Occurrence of major stroke or neurological death

    1 year

Secondary Outcomes (1)

  • Device related neurologic adverse event rate

    1 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neuroradiologists and surgeons practice

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Uniklinik Koln

Cologne, Germany

Location

Alfried Krupp Krankenhaus

Essen, Germany

Location

Hellenic Air Force Hospital

Athens, Greece

Location

IRCCS Fondazione Istituto Neurologico C Besta

Milan, Italy

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Queen Elizabeth Hospital Birmingham

Birmingham, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 30262655DERIVED

  • 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.

    PMID: 28223428DERIVED

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Edoardo Boccardi, M.D.

    Ospedale Niguarda "Ca' Granda"

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

November 4, 2016

Study Completion

November 4, 2016

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

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