flow diversion for Brain Aneurysm

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Ottawa Hospital, Ottawa, CanadaBrain Aneurysmconservative management - Other
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a flow diverter, a new device used to treat intracranial aneurysms, is effective and has an acceptable rate of complications.

Eligible Conditions
  • Brain Aneurysm

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: discharge, 3 and 12 months

12 months
angiographic outcome
rate of Adverse Events
rate of retreatment of index aneurysm
rate of success of therapy
30 days
rate of peri-operative complications
Month 12
modified Rankin score

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

2 Treatment Groups

flow diversion
1 of 2
Best standard treatment
1 of 2

Active Control

344 Total Participants · 2 Treatment Groups

Primary Treatment: flow diversion · No Placebo Group · N/A

flow diversion
Procedure
ActiveComparator Group · 1 Intervention: flow diversion · Intervention Types: Procedure
Best standard treatmentActiveComparator Group · 4 Interventions: conservative management, balloon parent vessel occlusion, endovascular coiling, surgical clipping · Intervention Types: Other, Procedure, Procedure, Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: discharge, 3 and 12 months

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
327 Previous Clinical Trials
113,543 Total Patients Enrolled
Centre de Recherche du Centre Hospitalier de l'Université de MontréalOTHER
49 Previous Clinical Trials
93,539 Total Patients Enrolled
Jean Raymond, MDPrincipal InvestigatorCentre Hospitalier de l'Université de Montréal - Hôpital Notre Dame
9 Previous Clinical Trials
4,387 Total Patients Enrolled

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an intracranial aneurysm that is considered difficult to treat and may require a flow diversion procedure. This may be due to the size, location, or previous treatment of the aneurysm. In rare cases, if the aneurysm has recently ruptured, the risks associated with antiplatelet drugs may make this treatment option unsuitable.

Frequently Asked Questions

Is it possible to participate in this medical experiment?

"This trial is prospectively enrolling 344 individuals between the ages of 18 and 75 who suffer from berry aneurysm. In order to meet inclusion criteria, patients must have a "difficult" intracranial aneurysm in which flow diversion can be seen as a suitable or best option for treatment by their clinician. These conditions may include symptomatic large or giant cavernous carotid, ophthalmic and vertebral aneurysms, fusiform intradural aneurysms, or recurring lesions that have not been addressed through coiling procedures previously. Moreover, this clinical trial will rarely accept" - Anonymous Online Contributor

Unverified Answer

How many individuals have signed up to take part in this experiment?

"Affirmative. Based on the information provided by clinicaltrials.gov, this medical trial is presently recruiting patients. It was first posted on May 2nd 2011 and most recently updated July 19th 2022. The study necessitates 344 participants from 3 separate locations to be recruited." - Anonymous Online Contributor

Unverified Answer

Is enrollment for this study still open?

"Clinicaltrials.gov shows that since it's initial posting on May 2nd 2011, this trial is presently seeking participants and was recently updated on July 19th 2022." - Anonymous Online Contributor

Unverified Answer

Is this study welcoming participants who are of legal age?

"This study requires that potential participants are of legal age and have not yet reached their 75th birthday." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.