Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study (PFLEX)

• ClinicalTrials.gov Identifier: NCT02390037
• Recruitment Status: Completed
• First Posted: March 17, 2015
• Last Update Posted: February 1, 2019
• Sponsor: Medtronic Neurovascular Clinical Affairs
• Information provided by (Responsible Party): Medtronic Neurovascular Clinical Affairs

Tracking Information

• First Submitted Date: March 6, 2015
• First Posted Date: March 17, 2015
• Last Update Posted Date: February 1, 2019
• Study Start Date: March 2015
• Actual Primary Completion Date: November 4, 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 10, 2015): Occurrence of major stroke or neurological death [ Time Frame: 1 year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: March 10, 2015): Device related neurologic adverse event rate [ Time Frame: 1 year ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
• Official Title: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
• 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™.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Neuroradiologists and surgeons practice
• Condition: Aneurysm
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• Martínez-Galdámez M, Lamin SM, Lagios KG, Liebig T, Ciceri EF, Chapot R, Stockx L, Chavda S, Kabbasch C, Faragò 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.
• Martínez-Galdámez 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 10, 2015): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 4, 2016
• Actual Primary Completion Date: November 4, 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Germany, Greece, Italy, Spain, United Kingdom

Administrative Information

• NCT Number: NCT02390037
• Other Study ID Numbers: NV PED 09
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medtronic Neurovascular Clinical Affairs
• Original Responsible Party: Medtronic - MITG
• Current Study Sponsor: Medtronic Neurovascular Clinical Affairs
• Original Study Sponsor: Medtronic - MITG
• Collaborators: Not Provided

Investigators

• Principal Investigator: Edoardo Boccardi, M.D.; Ospedale Niguarda "Ca' Granda"

• PRS Account: Medtronic Neurovascular Clinical Affairs
• Verification Date: January 2019