AneurysmPFLEXNCT02390037
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
An observational study of Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 7 sites in 6 countries.
Trial 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™. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysm
- How many people
- 50 participants
- Where
- 7 sitesin 6 countries
- Study dates
- Mar 2015to 4 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neuroradiologists and surgeons practice
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 6 countries.
7 sites in 6 countries
About this study
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.
- Conditions
- Aneurysm
- Medical subject headings
- Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of major stroke or neurological death
Measured: 1 year
Secondary outcomes (1)
Device related neurologic adverse event rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edoardo Boccardi, M.D., Principal investigator, Ospedale Niguarda "Ca' Granda"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390037
- Sponsor's protocol ID
- NV PED 09
- Acronym
- PFLEX
- Status last verified
- Jan 2019
- First submitted
- 6 Mar 2015
- Last updated
- 1 Feb 2019
- Results posted
- No
Publications
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.
PubMed 30262655Martinez-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.
PubMed 28223428
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
- ClinicalTrials.gov ID
- NCT02390037
- Acronym / sponsor ID
- PFLEX / NV PED 09
- Conditions
- Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuroradiologists and surgeons practice
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of major stroke or neurological death
Time frame: 1 year
1 secondary outcome
Device related neurologic adverse event rate
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Derived from this study: PubMed 30262655Martinez-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.
- Derived from this study: PubMed 28223428Martinez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo Boccardi, M.D. principal investigator
Ospedale Niguarda "Ca' Granda"
7 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 7 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Belgium, Greece, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major stroke or neurological death (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390037, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2019.