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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:
NCT02390037
First received: March 6, 2015
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Condition
Aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Further study details as provided by Medtronic Neurovascular Clinical Affairs:

Primary Outcome Measures:
  • Occurrence of major stroke or neurological death [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Device related neurologic adverse event rate [ Time Frame: 1 year ]

Enrollment: 50
Study Start Date: March 2015
Study Completion Date: November 4, 2016
Primary Completion Date: November 4, 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neuroradiologists and surgeons practice
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02390037

Locations
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
Investigators
Principal Investigator: Edoardo Boccardi, M.D. Ospedale Niguarda "Ca' Granda"
  More Information

Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT02390037     History of Changes
Other Study ID Numbers: NV PED 09
Study First Received: March 6, 2015
Last Updated: March 3, 2017

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 28, 2017