Studies
The Pivotal Study of RapidPulse Aspiration System as Frontline Approach for Patients with Acute Ischemic Stroke due to Large Vessel Occlusions (RapidPulse Pivotal Study)
A Prospective, Randomized, Dual-Arm, Multi-center Study to Assess the Safety and Effectiveness of Mechanical Thrombectomy Using the ANACONDA ANA5 Device in Combination with a Stent Retriever (ATHENA Trial)
Neurovascular Product Surveillance Registry (NV PSR) Base Clinical Investigation Plan Known as Innovative NeurovaScular Product SurveIllance REgistry (INSPIRE)
Clinical Investigation Plan of the Artisse Intrasaccular Device IDE (ARTISSE IDE)
CAR: Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices
StrokeNet Thrombectomy Endovascular Platform (STEP)
Safety, Performance and Lesion Evaluation of Neurothrombectomy using CEREGLIDE 92 Intermediate Catheter: A Prospective Multi-Center Single-Arm IDE Trial (SPLENDID)
Combined Thrombectomy for Distal Medium Vessel Occlusion Stroke (DUSK Trial)
A phase III, randomized, multi-center, investigational, open label clinical trial that will examine whether treatment with endovascular thrombectomy is superior to standard medical therapy alone in patients who suffer a Distal Medium Vessel Occlusion Ischemic Stroke within 12 hours from time last seen well
Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial (C2LOE)
Cognition in Subarachnoid Hemorrhage Survivors
RNA Expression Based Biomarkers of Brain Aneurysm
Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB® Device (WEB-PAS)
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. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.
Post-Approval Study Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
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. 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.
UDISCO
Ruptured cerebral aneurysms lead to subarachnoid hemorrhage (SAH),that has a high morbidity and mortality rate, the severity of which is predicted by the "Hunt-Hess grade" (HHG).
SAH leads to iron (Fe) and hemoglobin (Hb) accumulation in the brain, which is toxic for neurons. Ferritin (iron reported in the brian) and iron overload leads to brain atrophy, specifically in the mesial temporal lobe (hippocampus, impairing patients' cognition. It is estimated that 50% of survivors have cognitive deficits.
Most of the survivors of SAH could not return to work. Iron chelation therapy has been recently gaining ground as a therapeutic intervention in intraparenchymal hemorrhage and in SAH. However, there has not been any study that assess the iron deposition in the brain and the level of ferritin in the cerebrospinal fluid of SAH patients. The investigators propose to conduct a randomized trial using Deferiprone (oral chelating agent, "De") + standard of care versus standard of care in patient with SAH to:
1. assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube),
2. assess functional outcomes measured by the Montreal Cognitive Assessment (MoCA) score, a score used to assess the level of dementia, mainly in Alzheimer disease patients.
3. quantify the the total iron deposition in the brain based on MRI
Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)
This study will test the hypothesis that patients presenting within 8 hours of onset with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).
PHIL dAVF
This study is a prospective, multicenter, single-arm study. Patients with Dural Arteriovenous Fistulas (dAVF) have a few choice for safe treatment. In this study, all patients with qualifying dAVFs will be treated with PHIL® Liquid Embolic material.