| Condition or disease | Intervention/treatment |
|---|---|
| Intracranial Aneurysm | Device: FRED and FRED Jr |
This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FREDTM/FREDTM Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure.
150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
| Study Type : | Observational |
| Estimated Enrollment : | 150 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | FRED/FRED Jr Intracranial Aneurysm Treatment Study |
| Actual Study Start Date : | April 10, 2019 |
| Estimated Primary Completion Date : | April 30, 2021 |
| Estimated Study Completion Date : | September 30, 2024 |
Complete occlusion (Raymond Scale grade I) without stenosis of the parent artery.
Raymond scale definition: Grade I= complete occlusion of aneurysm, Grade II= Residual neck, Grade III= Residual aneurysm
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 15, 2019 | ||||||||
| First Posted Date | April 18, 2019 | ||||||||
| Last Update Posted Date | April 18, 2019 | ||||||||
| Actual Study Start Date | April 10, 2019 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | FRED/FRED Jr Intracranial Aneurysm Treatment Study | ||||||||
| Official Title | FRED/FRED Jr Intracranial Aneurysm Treatment Study | ||||||||
| Brief Summary | A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms | ||||||||
| Detailed Description |
This is a multi-center observational study. Treatment and follow-up visits will be performed as per standard of care. The purpose of this study is to demonstrate that use of the FREDTM/FREDTM Jr Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure. 150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients who are at least 18 years of age presenting with an unruptured or recanalized intracranial aneurysm requiring endovascular treatment. Those eligible to be treated with FRED/FRED Jr will be enrolled after having signed an informed consent form. | ||||||||
| Condition | Intracranial Aneurysm | ||||||||
| Intervention | Device: FRED and FRED Jr
Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
Other Name: Flow Re-Direction Endoluminal Device
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| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
150 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | September 30, 2024 | ||||||||
| Estimated Primary Completion Date | April 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Germany | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03920358 | ||||||||
| Other Study ID Numbers | CIP EMEA 18-01 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Microvention-Terumo, Inc. | ||||||||
| Study Sponsor | Microvention-Terumo, Inc. | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Microvention-Terumo, Inc. | ||||||||
| Verification Date | April 2019 | ||||||||