An observational study in Intracranial Aneurysms, sponsored by Microvention-Terumo, Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Microvention-Terumo, Inc. (part of Terumo Corporation) · Observational
Among 21 studies in Intracranial Aneurysm by Microvention-Terumo, Inc. — 3 open to participants now, 7 under way, none of them phase 3. Intracranial Aneurysm · Microvention-Terumo, Inc..
Among the 21 studies in Intracranial Aneurysm by Microvention-Terumo, Inc., this one is the 4th largest by planned enrollment of the 15 observational ones that give a count, is one of 2 that started in 2020, is one of 15 observational ones, and was the 18th registered.
418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.
Browse Intracranial Aneurysm studies →3 of the 21 studies in Intracranial Aneurysm by Microvention-Terumo, Inc. are open now, in 2 countries. Recruiting first, the newest first:
Microvention-Terumo, Inc. · Sites in Spain
Microvention-Terumo, Inc. · Sites in United States
Ages 18+
Microvention-Terumo, Inc.
Ages 18–90
By country, each count listing its studies:
Of the 82 Intracranial Aneurysm studies recruiting now, 49 (60%) set no upper age limit and 14 (17%) stop at 75 or younger; 15 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 2 started in 2020.
This study's planned enrollment of 250 is above the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.
Median enrollment 148 across the 6 interventional studies, 135 across the 15 observational. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
Microvention-Terumo, Inc. is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
2 of the studies in Intracranial Aneurysm by Microvention-Terumo, Inc. that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05409989Microvention-Terumo, Inc.MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study | 2027-04 |
| NCT06982781Microvention-Terumo, Inc.FRED Retrospective Study of Intracranial Aneurysms Treatment | 2027-05-06 |
Among the 21 studies in Intracranial Aneurysm by Microvention-Terumo, Inc., from their registry updates:
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The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.
The study population conforms to currently approved Indications for Use: Subjects with wide-necked (neck ≥ 4 mm or dome to neck ratio \< 2) intracranial, saccular aneurysms arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device since approval in the local geography of researched sizes.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The following criteria match the FDA-approved indications for use per PMA (P170013)
(Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS);
Appropriate or Waived Consent:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Complete or Stable Raymond Roy II
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. It is also known as the Raymond class, Montreal scale or the Raymond Montreal scale
Time frame: 5 year
Intracranial hemorrhage including SAH and IPH
Determined by adverse event adjudication by the clinical events committee
Time frame: 5 year
All ischemic and hemorrhagic stroke
Determined by adverse event adjudication by the clinical events committee
Time frame: 5 year
Neurological deaths
Determined by adverse event adjudication by the clinical events committee
Time frame: 5 year
Transient Ischemic Attack
Determined by adverse event adjudication by the clinical events committee
Time frame: 5 year
Parent artery patency
Determined by the corelab adjudication of images
Time frame: 5 year
In-stent stenosis
Determined by the corelab adjudication of images
Time frame: 5 year
Target aneurysm retreatment
Presented by the subject medical records
Time frame: 5 year
Cerebral vasospasm
Presented by the subject medical records
Time frame: 5 year
Ran from Nov 2020 to primary completion in Mar 2025, 52 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Oct 2025 → Mar 2025 and completion Jan 2026 → Jan 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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