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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02390037
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : February 1, 2019
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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