Clinical trial NCT05409989: MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Official title: MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 154
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study.


Eligibility criteria: Inclusion Criteria:

Subjects for this study must meet ALL the following criteria:

1. Subject has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery.
2. The parent artery diameter must be 2.0 - 5.0 mm distal and/or proximal to the target intracranial aneurysm.
3. Negative pregnancy test (serum or urine) in a female subject who has had menses in the last 18 months.
4. 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.
5. The subject or his/her authorized representative must sign the IRB-approved written informed consent form prior to the start of any study procedures.
6. The subject has a modified Rankin Scale (mRS) ≤ 2.
7. The subject has a wide-necked ( ≥4mm or dome-to-neck ratio \<2) saccular or fusiform aneurysm.

Exclusion Criteria:

Subjects shall be excluded from the study if ANY of the following conditions exist:

1. Subject who suffers from a subarachnoid hemorrhage in the last 60 days.
2. Subject who suffers from intracranial hemorrhage in the last 30 days.
3. Subject who presents with an intracranial mass or currently undergoing radiation therapy for carcinoma of the head or neck region.
4. Subject with symptomatic extracranial or intracranial stenosis of the parent artery (\>50%) proximal to the target aneurysm.
5. 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.
6. Subject with history of major bleeding disorder (based on coagulation profile and platelet count) and/or subject presents with signs of active bleeding.
7. Subject with known hypersensitivity to any component of the treatment device that cannot be medically controlled.
8. Subject with documented contrast allergy, or other condition that prohibits imaging.
9. Evidence of active bacterial infection at the time of treatment.
10. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
11. Subject with a pre-existing stent in place at the target aneurysm.
12. Subject who is unable to complete the required follow-ups.
13. Subject who is pregnant, breastfeeding, or of childbearing potential and unwilling to prevent pregnancy during their participation in the study.
14. Subject has a serious or life-threatening comorbidity that could confound study results and/or prevent completion of 5-year followup.
15. Subject is enrolled in another device or drug study in which participation could confound study results.
16. Subject has absent femoral pulses or other condition preventing femoral access, or is planned to be treated using a radial access approach.

Primary outcomes:
measure: Primary Safety Endpoint Part 1: Proportion of subjects that experience either Death or major stroke within 30 days post-procedure.
timeFrame: 30-days
measure: Primary Safety Endpoint Part 2: Proportion of subjects that experience neurological death or major ipsilateral stroke within 12 months post-procedure.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare Systems
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas
state: Kansas
city: Louisville
country: United States
facility: Baptist Healthcare System
state: Kentucky
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Health
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Brigham Incorporated
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Health
state: Massachusetts
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Manhasset
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Riverside Research Institute
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: