Intracranial AneurysmMAX-PIPENCT03161769
MAXimizing Flow Diversion Effect On the Treatment of Large Intracranial Aneurysms With Embolization Devices
An observational study of Intracranial Aneurysm, run by University Health Network, Toronto at 1 site in Canada.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Neurovascular treatment of intracranial aneurysms and AneurysmFlow image processing software
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 21 Apr 2017to 1 Sep 2019
- How long will I take part?
- 30 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with unruptured saccular Intracranial Aneurysms IA(s) suitable for endovascular treatment with PIPEline™ Embolization Devices or PIPEline™ Flex Embolization Devices.
Who may be able to join
- 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.
- Subject has signed an institutionally approved research informed consent form.
- Subject ≥ 18 years old.
Who cannot join
- Subject with non-saccular brain aneurysm (s) such as:- dissecting; fusiform; atherosclerotic; mycotic; bifurcational.
- Subject underwent a prior target brain aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
- The endovascular treatment of subject's target aneurysm(s) was assisted with coils or intracranial stents (non-FDS) before the AneurysmFlow calculations.
- Subject with partially thrombosed or recanalized target brain aneurysm(s).
- Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
- Subject with severe kidney disease (e-GFR < 60).
- Subject is not willing (or not able) to attend post FDS insertion follow up clinic visits requiring DSA, head MRI or CTA imaging.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital - University Health Network
Toronto, Ontario, M5T 2S8
Vitor Pereira, MD, 416-603-5800 ext. 5564, vitor.pereira@uhn.ca
Alex Kostynskyy, MBBS, 416-603-5800 ext. 4806, alex.kostynskyy@uhn.ca
About this study
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"
Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist with the treatment of intracranial large aneurysms using Embolization Device(s)
Read the 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
- Being tested
- Neurovascular treatment of intracranial aneurysms, AneurysmFlow image processing software
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurovascular treatment of intracranial aneurysmsProcedure or surgery
Endovascular treatment of intracranial aneurysms using flow diverting stents
AneurysmFlow image processing softwareDevice
Software to process and display images of intracranial aneurysm treatment using flow diverting stents.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous neurovascular treatment | Procedure: Percutaneous neurovascular treatment of intracranial aneurysms Receives: Procedure: Neurovascular treatment of intracranial aneurysms; Device: AneurysmFlow image processing software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start21 Apr 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Vitor Pereira, University Health Network, Toronto
- Investigators
- Vitor Pereira, MD, Principal investigator, Associate Professor or Radiology and Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161769
- Sponsor's protocol ID
- TWH -Version 4.0 July 13 2016
- Acronym
- MAX-PIPE
- Status last verified
- Oct 2018
- First submitted
- 17 May 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03161769
- Acronym / sponsor ID
- MAX-PIPE / TWH -Version 4.0 July 13 2016
- Conditions
- Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous neurovascular treatment | – | Procedure: Neurovascular treatment of intracranial aneurysms, Device: AneurysmFlow image processing softwareProcedure: Percutaneous neurovascular treatment of intracranial aneurysms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with unruptured saccular Intracranial Aneurysms IA(s) suitable for endovascular treatment with PIPEline™ Embolization Devices or PIPEline™ Flex Embolization Devices.
Key inclusion criteria (3 listed)
- 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.
- Subject has signed an institutionally approved research informed consent form.
- Subject ≥ 18 years old.
Key exclusion criteria (7 listed)
- Subject with non-saccular brain aneurysm (s) such as:- dissecting; fusiform; atherosclerotic; mycotic; bifurcational.
- Subject underwent a prior target brain aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques.
- The endovascular treatment of subject's target aneurysm(s) was assisted with coils or intracranial stents (non-FDS) before the AneurysmFlow calculations.
- Subject with partially thrombosed or recanalized target brain aneurysm(s).
- Subject had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurovascular treatment of intracranial aneurysmsEndovascular treatment of intracranial aneurysms using flow diverting stents | Procedure or surgery | Percutaneous neurovascular treatment |
| AneurysmFlow image processing softwareSoftware to process and display images of intracranial aneurysm treatment using flow diverting stents. | Device | Percutaneous neurovascular treatment |
Primary outcome
Number of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography.
Time frame: 1 year
≥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.
3 secondary outcomes
Number of participants with complete aneurysm occlusion at 6 months based on contrast agent volume measurement in angiography.
Time frame: 6 months
High sensitivity and specificity (> 80%) of the MAFA ratio to determine aneurysm occlusion rates based on ROC statistical calculations.
Time frame: 1 year
Number of participants with treatment complications as assessed by an electronic patient record.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vitor Pereira, MD principal investigator
Associate Professor or Radiology and Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vitor Pereira, MD (416-603-5800 ext. 5564, vitor.pereira@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete aneurysm occlusion at 12 months based on contrast agent volume measurement in angiography. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.