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

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"

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

Study Overview

• Status: Unknown
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Procedure: Neurovascular treatment of intracranial aneurysms; Device: AneurysmFlow image processing software

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

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Vitor Pereira, MD; Phone Number: 5564 416-603-5800; Email: vitor.pereira@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital - University Health Network
      • Contact: Vitor Pereira, MD; Phone Number: 5564 416-603-5800; Email: vitor.pereira@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Percutaneous neurovascular treatment; Procedure: Percutaneous neurovascular treatment of intracranial aneurysms	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography.	≥86% complete aneurysm occlusion rate after 12 months post-treatment using optical flow analysis with a MAFA threshold ratio of 0.89, measured with an image processing tool.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with complete aneurysm occlusion at 6 months based on contrast agent volume measurement in angiography.	≥74% complete aneurysm occlusion rate after 6 months post-treatment using optical flow analysis with a MAFA threshold ratio of 0.89, measured with an image processing tool.	6 months
High sensitivity and specificity (> 80%) of the MAFA ratio to determine aneurysm occlusion rates based on ROC statistical calculations.	Data collected from the registry will be used to help determine a new, more optimal MAFA ratio threshold for predicting post-FDS aneurysm occlusion at 12 months post-treatment based on receiver operating characteristic (ROC) statistical curves.	1 year
Number of participants with treatment complications as assessed by an electronic patient record.	Predictability of the MAFA ratio for treatment complications (aneurysm rupture, in-stent thrombosis, mass effect, using a correlation analysis.	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Philips Healthcare
• Investigators: Principal Investigator: Vitor Pereira, MD, Associate Professor or Radiology and Surgery

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 21, 2017
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (ACTUAL): May 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: TWH -Version 4.0 July 13 2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No