Status:
WITHDRAWN
Canadian Study of the MicroVention Flow Re-Direction (FRED) Endoluminal Device Stent System in the Treatment of Intracranial Aneurysms
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Intracranial Aneurysms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study objective is to evaluate the safety and effectiveness of the MicroVention FRED System when used in the treatment of wide-necked intracranial aneurysms.
Eligibility Criteria
Inclusion
- Subject whose age is ≥ 18 years;
- Subject has a single target aneurysm located in the following zones:
- Zone 1 - Petrous through cavernous of the ICA
- Zone 2 - Ophthalmic segment of the ICA
- Zone 3-Posterior Circulation, basilar artery (not including the basilar bifurcation), vertebral artery
- Subjects with a single target intracranial aneurysm located along the internal carotid artery, or the vertebral or basilar artery for whom existing endovascular options (coiling, stent-assisted-coiling) could be ineffective or because aneurysm is predisposed to recurrence due to having any of the following characteristics:
- Aneurysms with a neck \> 4mm, dome to neck ratio ≤2 or no discernible neck
- Fusiform aneurysms of any size requiring treatment;
- The parent artery must have a diameter of 2.5 - 5.0mm distal/proximal to the target intracranial aneurysm (IA);
- Subject fulfills study requirements, and the subject or his/her legally authorized representative provides a signed informed consent form;
- Negative pregnancy test in a female subject who has had menses in the last 24 months;
- Subject is willing to return for the 1-month and 6-month follow-up evaluations
Exclusion
- Subject who is pregnant or breastfeeding; Subject who suffers from a subarachnoid hemorrhage in the last 60 days;
- Subject who suffers from any intracranial hemorrhage in the last 30 days;
- Subject currently undergoing radiation therapy for carcinoma or sarcoma of the head or neck region;
- Subject with stenosis of the parent artery (\>50%) proximal to the target aneurysm;
- Subject with known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents;
- Subject with contraindications or severe allergies to anticoagulants or antiplatelet medications (aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor);
- Subject with known hypersensitivity to metal, such as nickel-titanium and metal jewelry
- Subject with documented contrast allergy, or other condition, that prohibits imaging.
- Evidence of active bacterial infection at the time of treatment;
- Subject who has had a previous intracranial stenting procedure associated with the target aneurysm;
- Subject with life-threatening diseases.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02309203
End Date
September 1 2017
Last Update
July 28 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.