Clinical trial NCT03161769: MAXimizing Flow Diversion Effect On the Treatment of Large Intracranial Aneurysms With Embolization Devices
Official title: 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"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Aneurysm
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2017-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with unruptured saccular Intracranial Aneurysms IA(s) suitable for endovascular treatment with PIPEline™ Embolization Devices or PIPEline™ Flex Embolization Devices.

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography.
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with complete aneurysm occlusion at 6 months based on contrast agent volume measurement in angiography.
timeFrame: 6 months
measure: High sensitivity and specificity (> 80%) of the MAFA ratio to determine aneurysm occlusion rates based on ROC statistical calculations.
timeFrame: 1 year
measure: Number of participants with treatment complications as assessed by an electronic patient record.
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital - University Health Network
state: Ontario
Study officials:
affiliation: Associate Professor or Radiology and Surgery
name: Vitor Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: