Overview

This trial is active, not recruiting.

Condition intracranial aneurysm
Treatment pipeline™ embolization device/ pipeline™flex embolization device
Sponsor Medtronic Neurovascular Clinical Affairs
Start date July 2014
End date March 2017
Trial size 141 participants
Trial identifier NCT02186561, NCT02178007, NV-PED-07

Summary

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
treatment with Pipeline™ Embolization Device
pipeline™ embolization device/ pipeline™flex embolization device

Primary Outcomes

Measure
Occurrence of major stroke or neurological death
time frame: 1 year
Complete aneurysm occlusion
time frame: 1 year

Secondary Outcomes

Measure
Occurrence of major stroke or neurological death
time frame: 30 day

Eligibility Criteria

Male or female participants from 22 years up to 80 years old.

Inclusion Criteria: - Subject has provided written informed consent using the IRB/EC-approved consent form and agrees to comply with protocol requirements. - Age 22-80 years. - Subject has a target intracranial aneurysm (IA) located in the anterior or posterior circulation. - Subject has a target IA with a wide aneurysm neck. Exclusion Criteria: - Subject has received an intracranial implant (e.g. coils) in the area of the target IA within the past 12 weeks. - Major surgery in the last 30 days. - History of irreversible bleeding disorder and/or subject presents with signs of active bleeding. - Any known contraindication to treatment with the Pipeline™ device. - Pregnant women. - Participating in another clinical trial.

Additional Information

Official title PREMIER PROSPECTIVE STUDY ON EMBOLIZATION OF INTRACRANIAL ANEURYSMS WITH PIPELINE™ EMBOLIZATION DEVICE
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Medtronic Neurovascular Clinical Affairs.