Clinical trials: sponsored by Microvention-Terumo, Inc.
Intracranial Aneurysm
Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component.
- Trial name
- WEB-RWS (NCT07620626)
- Testing
- Intrasaccular Flow Disruption Device
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xuanwu Hospital, Beijing
Acute Ischemic Stroke
REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke
The objective of this study is to evaluate the safety and effectiveness of the SOFIA Flow 88 Aspiration Catheter for treatment of acute ischemic stroke.
- Trial name
- REVIVE (NCT07216170)
- Testing
- SOFIA Flow 88 Aspiration Catheter
- Volunteers
- 200 people
- Sponsor
- Microvention-Terumo, Inc.
Chronic Subdural Hematomas
PHIL™ Middle Meningeal Artery Embolization for First-Line Treatment of Chronic Subdural Hematoma IDE Trial
This is a prospective, randomized, controlled, open-label, blinded endpoint (PROBE) clinical investigation in which patients with non-emergent chronic subdural hematoma (cSDH) requiring treatment will be randomized (1:1) to…
- Trial name
- PHILFIRST (NCT07576998)
- Testing
- PHIL™ (Precipitating Hydrophobic Injectable Liquid), Surgical evacuation
- Volunteers
- 475 people
- Sponsor
- Microvention-Terumo, Inc.
Wide Neck Bifurcation Intracranial Aneurysms
Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device
A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation.
- Trial name
- WEB PAS (NCT04839705)
- Testing
- WEB
- Where
- 27 sites in United States
- Volunteers
- 195 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
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.
- Trial name
- NCT05409989
- Testing
- FRED™ X™
- Where
- 23 sites in United States
- Volunteers
- 154 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Microvention AnEurysm & STroke Real-life Data cOllection
The MAESTRO registry is a post-market, single-arm, non-interventional, multicenter registry
- Conditions
- Intracranial Aneurysm, Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion, Aneurysmal Subarachnoid Hemorrhage, Ischemic Stroke
- Trial name
- MAESTRO (NCT06494436)
- Testing
- All Microvention Class III implantable device CE marked, All Microvention Mechanical Thrombectomy Class III device CE marked
- Where
- Spain
- Volunteers
- 1,000 people
- Sponsor
- Microvention-Terumo, Inc.
Aneurysm Cerebral
Complex Aneurysm Registry - Real-World Evidence Data Collection Intracranial Aneurysm Treatment Devices
To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of…
- Trial name
- CAR (NCT06215105)
- Testing
- Intracranial Aneurysm Devices
- Where
- 5 sites in United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01541254)
- Testing
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01793792)
- Testing
- LVIS™ and LVIS™ Jr
- Where
- 21 sites in United States
- Volunteers
- 153 people
- Sponsor
- Microvention-Terumo, Inc.
Acute Ischemic Stroke, Vessel Occlusion
REal-World Analyses of Stroke - Thrombus Occlusion REtrieval
To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician.
- Conditions
- Acute Ischemic Stroke, Vessel Occlusion, Stroke, Ischemic
- Trial name
- "RESTORE" (NCT04451525)
- Testing
- MicroVention Mechanical Thrombectomy Devices as first-line treatment
- Where
- 37 sites in United States
- Volunteers
- 710 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS Device
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.
- Trial name
- LVIS PAS (NCT05453240)
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
FRED Retrospective Study of Intracranial Aneurysms Treatment
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment
- Trial name
- FRED (NCT06982781)
- Testing
- Flow Re-Direction Endoluminal Device System(FRED)
- Volunteers
- 2,000 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
FRED/ FRED Jr/ FRED X Intracranial Aneurysm Treatment Study
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
- Trial name
- FRITS (NCT03920358)
- Testing
- FRED, FRED Jr and FRED X
- Where
- Germany
- Volunteers
- 156 people
- Sponsor
- Microvention-Terumo, Inc.
Cerebrovascular Stroke
BOBBY™ Balloon Guide Catheter for Endovascular Treatment of Acute Ischemic Stroke
Evaluation of the safety and performance of the BOBBY™ Balloon Guide Catheter (BGC) in patients with an acute ischemic stroke treatment, a sudden reduction or termination of the blood circulation of the brain, caused by a clot.
- Trial name
- STRAIT (NCT05361187)
- Testing
- BOBBY™ Balloon Guide Catheter intended for use in neurovascular procedures, performing or as an adjunctive device
- Where
- 9 sites in Germany, Switzerland
- Volunteers
- 171 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysms
TRAIL: Treatment of Intracranial Aneurysms With LVIS® System
A prospective, multicenter, observational assessment of the safety and effectiveness of the LVIS® device in the treatment of wide necked intracranial aneurysms.
- Trial name
- TRAIL (NCT02921711)
- Testing
- LVIS®
- Volunteers
- 90 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment
This is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective…
- Trial name
- SEALANT (NCT04999423)
- Testing
- LVIS EVO and HydroCoil Embolic System
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 206 people
- Sponsor
- Microvention-Terumo, Inc.
Arteriovenous Dural Fistula
PHIL in the Treatment of Intracranial dAVF.
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment.
- Trial name
- PHIL dAVF (NCT03467542)
- Testing
- PHIL® Liquid Embolic System
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Microvention-Terumo, Inc.
Wide Neck Bifurcation Intracranial Aneurysms, Intracranial Aneurysms
The WEB-IT Clinical Study
The study is a prospective, multicenter single-arm cohort. Patients with wide neck bifurcation aneurysms (WNBAs) have few choices for safe and effective endovascular treatment.
- Trial name
- WEB-IT (NCT02191618)
- Testing
- WEB
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 150 people
- Sponsor
- Microvention-Terumo, Inc.
Ruptured Aneurysm
European, Multi-center, Exploratory Trial to Assess WEB Versus Other Endovascular Treatment in Ruptured Aneurysms.
Comparison of efficacy and safety between WEB and other endovascular techniques
- Trial name
- WAVE (NCT06511245)
- Testing
- Randomisation
- Where
- France
- Volunteers
- 80 people
- Sponsor
- Microvention-Terumo, Inc.
Ruptured Aneurysm
Ruptured Aneurysms Treated With Hydrogel Coils
To determine safety and occlusion rates when second-generation hydrogel coils are used in the treatment of ruptured intracranial aneurysms.
- Trial name
- RAGE (NCT03252314)
- Testing
- Second-generation hydrogel coils
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Microvention-Terumo, Inc.