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OpenTrials
Completed

NCT Number: NCT02390037

Pipeline™ Flex Embolization Device With Shield Technology™ Clinical 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™.

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Key information

Conditions

Aneurysm Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Occurrence of major stroke or neurological death

    Time frame: 1 year

Secondary outcomes

  1. Device related neurologic adverse event rate

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Medtronic Neurovascular Clinical Affairs

Industry

Registry information

Acronym: PFLEX

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 17, 2015
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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