MAXimizing Flow Diversion Effect On the Treatment of Large Intracranial Aneurysms With Embolization Devices (MAX-PIPE)

University Health Network, Toronto

Status: Unknown

Conditions: Intracranial Aneurysm

Treatments: Device: AneurysmFlow image processing software; Procedure: Neurovascular treatment of intracranial aneurysms

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03161769

TWH -Version 4.0 July 13 2016

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject with unruptured, large (≥8mm) saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent.
2. Subject has signed an institutionally approved research informed consent form.
3. Subject ≥ 18 years old.

Exclusion criteria

1. Subject with non-saccular brain aneurysm (s) such as:- dissecting; fusiform; atherosclerotic; mycotic; bifurcational.
2. Subject underwent a prior target brain aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
3. The endovascular treatment of subject's target aneurysm(s) was assisted with coils or intracranial stents (non-FDS) before the AneurysmFlow calculations.
4. Subject with partially thrombosed or recanalized target brain aneurysm(s).
5. Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
6. Subject with severe kidney disease (e-GFR < 60).
7. Subject is not willing (or not able) to attend post FDS insertion follow up clinic visits requiring DSA, head MRI or CTA imaging.

Trial design

30 participants in 1 patient group

Percutaneous neurovascular treatment

Description:

Procedure: Percutaneous neurovascular treatment of intracranial aneurysms

Treatment:

Procedure: Neurovascular treatment of intracranial aneurysms

Device: AneurysmFlow image processing software