MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FREDâ„¢ Xâ„¢) Post-Approval Study (NCT05409989) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FREDâ„¢ Xâ„¢) Post-Approval Study
United States154 participantsStarted 2022-09-20
Plain-language summary
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FREDâ„¢ Xâ„¢ device with the performance of the FREDâ„¢ device. The data generated from this study will be compared to the safety and effectiveness of the FREDâ„¢ device by meeting the same performance goals (PGs) established for the FREDâ„¢ pivotal study.
Who can participate
Age range22 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery.
✓. The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm.
✓. Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months.
✓. Subject commits to return to the investigational site for the 30- day, 6-month, 12-month, 2-year, 3-year, and 5-year follow-up evaluations.
✓. The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures.
✓. The subject has a modified Rankin Scale (mRS) ≤ 2.
✓. The subject has a wide-necked ( ≥4mm or dome-to-neck ratio \<2) saccular or fusiform aneurysm.
Exclusion criteria
✕. Subject who suffers from a subarachnoid hemorrhage in the last 60 days.
✕. Subject who suffers from intracranial hemorrhage in the last 30 days.
✕. Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
✕. Subject with symptomatic extracranial or intracranial stenosis of the parent artery (\>50%) proximal to the target aneurysm.
What they're measuring
1
Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
Timeframe: 30-days
2
Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.
Timeframe: 12 months
3
Primary Effectiveness Endpoint: The percent of subjects with (1) complete (100%) occlusion of the target aneurysm and ≤50% stenosis of the parent artery at the target IA, and (2) in whom an alternative treatment of the target IA had not been performed.
. Subject with an irreversible bleeding disorder, a platelet count \< 100 x 103 cells/mm3 or known platelet dysfunction or a contraindication to or inability to tolerate anticoagulants/antiplatelet agents or thrombolytic drugs.
✕. Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
✕. Subject with known hypersensitivity to any component of the treatment device that cannot be medically controlled.
✕. Subject with documented contrast allergy, or other condition that prohibits imaging.