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NCT02390037 Clinical Trial

Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Aneurysm Clinical Trial

— PFLEX  

Official title:
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02390037
Other study ID # NV PED 09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date November 4, 2016

Study information
Verified date January 2019
Source Medtronic Neurovascular Clinical Affairs
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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™.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date November 4, 2016
Est. primary completion date November 4, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Ziekenhuis Oost-Limburg Genk
Germany Alfried Krupp Krankenhaus Essen
Germany Uniklinik Koln Koln
Greece Hellenic Air Force Hospital Athens
Italy IRCCS Fondazione Istituto Neurologico C Besta Milan
Spain Hospital Clinico Universitario de Valladolid Valladolid
United Kingdom Queen Elizabeth Hospital Birmingham Birmingham

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Neurovascular Clinical Affairs

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Italy,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of major stroke or neurological death 1 year
Secondary Device related neurologic adverse event rate 1 year
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