Recruiting

Flow Diversion

Sponsor:

University Health Network, Toronto

Code:

NCT03161769

Conditions

Intracranial Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurovascular treatment of intracranial aneurysms

AneurysmFlow image processing software

Study Details

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)

Conditions

Intracranial Aneurysm

Study ID

NCT03161769

Start date

Apr 21, 2017

Status verified date

Oct, 2018

Completion date

Sep 1, 2019

Anticipated

Primary completion date

Sep 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

Percutaneous neurovascular treatment

Procedure: Percutaneous neurovascular treatment of intracranial aneurysms

Interventions

Neurovascular treatment of intracranial aneurysms

Endovascular treatment of intracranial aneurysms using flow diverting stents

AneurysmFlow image processing software

Software to process and display images of intracranial aneurysm treatment using flow diverting stents.

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 ]

Central Contacts and Locations

Central contacts

Locations

Toronto Western Hospital - University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Principal Investigator:

Vitor Pereira, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 16, 2018

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2018-10-16.