Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study

Medtronic Neurovascular Clinical Affairs50 enrolled

Overview

The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Aneurysm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (7)

Ziekenhuis Oost-Limburg

Genk, Belgium

Uniklinik Koln

Cologne, Germany

Alfried Krupp Krankenhaus

Essen, Germany

Hellenic Air Force Hospital

Athens, Greece

Outcomes

Primary Outcomes

Occurrence of major stroke or neurological death

Time frame: 1 year

Secondary Outcomes

Device related neurologic adverse event rate

Time frame: 1 year

Data from ClinicalTrials.gov

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