Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Completed

• Conditions: Aneurysm

• Registration Number: NCT02390037
• Lead Sponsor: Medtronic Neurovascular Clinical Affairs

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 available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-17
• Primary Completion: 2016-11-04
• Study Completion: 2016-11-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of major stroke or neurological death	1 year

Secondary Outcome Measures

Name	Time	Method
Device related neurologic adverse event rate	1 year

Trial Locations

Locations (7)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Alfried Krupp Krankenhaus; 🇩🇪 Essen, Germany

Uniklinik Koln; 🇩🇪 Koln, Germany

Hellenic Air Force Hospital; 🇬🇷 Athens, Greece

IRCCS Fondazione Istituto Neurologico C Besta; 🇮🇹 Milan, Italy

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Queen Elizabeth Hospital Birmingham; 🇬🇧 Birmingham, United Kingdom