NCT03161769

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2017

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

2.4 years

First QC Date

May 17, 2017

Last Update Submit

October 15, 2018

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Number of participants with complete aneurysm occlusion at 6 months based on contrast agent volume measurement in angiography.

    6 months

  • High sensitivity and specificity (> 80%) of the MAFA ratio to determine aneurysm occlusion rates based on ROC statistical calculations.

    1 year

  • Number of participants with treatment complications as assessed by an electronic patient record.

    1 year

Study Arms (1)

Percutaneous neurovascular treatment

Procedure: Percutaneous neurovascular treatment of intracranial aneurysms

Procedure: Neurovascular treatment of intracranial aneurysmsDevice: AneurysmFlow image processing software

Interventions

Neurovascular treatment of intracranial aneurysmsPROCEDURE

Endovascular treatment of intracranial aneurysms using flow diverting stents

Percutaneous neurovascular treatment
AneurysmFlow image processing softwareDEVICE

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

Percutaneous neurovascular treatment

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital - University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Officials

  • Vitor Pereira, MD

    Associate Professor or Radiology and Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitor Pereira, MD

CONTACT

416-603-5800vitor.pereira@uhn.ca

Alex Kostynskyy, MBBS

CONTACT

416-603-5800alex.kostynskyy@uhn.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiology and Surgery

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 22, 2017

Study Start

April 21, 2017

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)