NCT03161769

MAXimizing Flow Diversion Effect On the Treatment of Large Intracranial Aneurysms With Embolization Devices

MAX-PIPE Registry - Maximizing Flow Diversion Effect On The Treatment of Large Intracranial Aneurysms With PIPEline Flex Embolization Devices Using Optical Flow Imaging Software "AneurysmFlow"

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist with the treatment of intracranial large aneurysms using Embolization Device(s)

Detailed description

The Division of Neuroradiology at UHN (Toronto Western Hospital) would like to initiate a single center registry study on the treatment of large intracranial aneurysms with PIPEline\[tm\] flex embolization devices using optical flow imaging software, "AneurysmFlow". The study team will consent patients diagnosed with unruptured brain / intracratial aneurysms IA(s) . The selected patients ,who booked for elective brain aneurysm repair/endovascular treatment with Flow diverter devices (FDS) called Pipeline embolization devices (PED), will qualify for registry participation . During the PED procedure, the study team will be using AneurysmFlow software to calculate a new metric called the MAFA ratio (Mean Aneurysm Flow Amplitude). By calculating the MAFA ratios intra-operatively, the interventionalist can adapt the therapeutic strategy in order to maximize the flow diverting effect on inducing complete aneurysm occlusions (thrombosis). Additionally, the purpose of this study is to further expand the body of clinical knowledge concerning the relationship between blood flow metrics as determined by the AneurysmFlow software and clinical outcome in patients undergoing treatment for intracranial aneurysms (IAs) with Pipeline and Pipeline Flex embolization devices. The study team aims to collect data at a 12 month follow-up period for each patient

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
PROCEDURE	Neurovascular treatment of intracranial aneurysms	Endovascular treatment of intracranial aneurysms using flow diverting stents
DEVICE	AneurysmFlow image processing software	Software to process and display images of intracranial aneurysm treatment using flow diverting stents.

Timeline

• Start date: 2017-04-21
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-05-22
• Last updated: 2018-10-16

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study