15 completed, 2 terminated, 1 withdrawn. 3 Phase 1, 2 Phase 2, 2 Phase 3, 2 Phase 4, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Phase 4 | 2 | Completed 2 |
| Early Phase 1 | 1 | Completed 1 |
| Not applicable | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluation of the ReVive SE Device for Intra-Arterial Thrombectomy in Acute Ischemic Stroke Stroke | Completed | Codman & Shurtleff | 103 | 2015-01-01 | 2017-08-07 | |
| Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms DeltaMaxx Microcoil System - Intracranial Aneurysms | Withdrawn | Codman & Shurtleff | 2014-01-01 | 2014-07-03 | ||
| Long-term Surveillance of the MedStream Programmable Infusion System MedStream Programmable Infusion System - Spasticity | Terminated | Codman & Shurtleff | 2 | 2012-10-01 | 2019-01-23 | |
| TRUfill®'s Line in Intracranial aNeurysm Embolisation Aneurysms | Completed | Codman & Shurtleff | 171 | 2011-12-01 | 2017-06-20 | |
| Selective Nerve Stimulation (SNS) Pilot Study Selective Nerve Stimulation (SNS) stimulator device - Healthy, Pain | Early Phase 1 | Completed | Codman & Shurtleff | 60 | 2010-11-01 | 2019-10-18 |
| Enterprise Stent Aneurysm Treatment (ESAT) Study - France Intracranial Aneurysm | Completed | Codman & Shurtleff | 133 | 2009-02-01 | 2013-10-11 | |
| VISSIT Intracranial Stent Study for Ischemic Therapy Pharos Vitesse Neurovascular Stent System (Stent implantation) + Medical therapy (Aspirin and Clopidogrel), Aspirin and Clopidogrel (Medical therapy) - Ischemic Stroke, Transient Ischemic Attack | Phase 2 / Phase 3 | Terminated | Codman & Shurtleff | 125 | 2008-10-01 | 2015-02-20 |
| The Registry to Study Safety and Performance of the CORDIS Vascular Reconstruction Device and Delivery System Vascular Reconstruction Device - Intracranial Aneurysm | Completed | Codman & Shurtleff | 105 | 2007-06-01 | 2018-12-12 | |
| A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries Cordis Neurovascular ENTERPRISE Self Expanding Stent System - Atherosclerosis, Aneurysm | Phase 1 | Completed | Codman & Shurtleff | 20 | 2006-09-01 | 2014-06-30 |
| A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Shunt catheter - Hydrocephalus | Completed | Codman & Shurtleff | 433 | 2006-01-01 | 2013-03-08 | |
| The Effectiveness of Pain Management Using the ARCHIMEDES® Constant-Flow Infusion Pump System for Intrathecal Delivery Archimedes Constant Flow Implantable Pump - Chronic Pain | Phase 4 | Completed | Codman & Shurtleff | 55 | 2005-03-01 | 2012-05-02 |
| Comparative Infection Rates for the Codman BACTISEAL TM External Ventricular Drainage (EVD) System Bactiseal TM EVD, Standard EVD Catheter - Intraventricular Hemorrhage, Subarachnoid Hemorrhage | Phase 4 | Completed | Codman & Shurtleff | 434 | 2004-11-01 | 2013-11-05 |
| Normal Pressure Hydrocephalus (NPH) Registry Normal Pressure Hydrocephalus | Completed | Codman & Shurtleff | 343 | 2004-10-01 | 2010-02-08 | |
| Study to Evaluate Efficacy of Shunt Operation for Idiopathic Normal Pressure Hydrocephalus ventriculo-peritoneal shunt - Idiopathic Normal Pressure Hydrocephalus | Phase 2 | Completed | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | 110 | 2004-09-01 | 2009-02-09 |
| A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Codman VPV System - Hydrocephalus, Normal Pressure Hydrocephalus | Phase 3 | Completed | Codman & Shurtleff | 274 | 2004-09-01 | 2012-05-28 |
| The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System Cordis Self Expanding Stent - Aneurysms | Phase 1 | Completed | Codman & Shurtleff | 31 | 2004-06-01 | 2012-05-02 |
| COMPLEX Post Market Surveillance Electronic Registry Endovascular Embolization Device - Intracranial Aneurysm | Not applicable | Completed | Codman & Shurtleff | 299 | 2004-06-01 | 2012-05-17 |
| Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms Cordis Neurovascular Self-Expanding Stent - Intracranial, Wide-Neck, Saccular Aneurysms | Phase 1 | Completed | Codman & Shurtleff | 30 | 2004-01-01 | 2009-01-07 |
Aneurysm (5) · Intracranial Aneurysm (4) · Hydrocephalus (3) · Hydrocephalus, Normal Pressure (2) · Atherosclerosis (1) · Chronic Pain (1) · Ischemic Attack, Transient (1) · Ischemic Stroke (1) · Motor Neuron Disease (1) · Muscle Rigidity (1) · Muscle Spasticity (1) · Pain (1) · Reflex, Abnormal (1) · Rupture (1) · Stroke (1)
Aspirin (1) · Clopidogrel (1) · Ventriculoperitoneal Shunt (1)
United States (6) · France (5) · Canada (2) · China (2) · Hong Kong (2) · Japan (2) · Singapore (2) · United Kingdom (2) · Argentina (1) · Belgium (1) · Germany (1) · India (1) · Italy (1) · Norway (1)
Anthony Marmarou, Ph.D. (1) · Bendszus Martin, MD (1) · Benjamin Hoehn, MD (1) · Bernard Bendok, M.D. (1) · Boris Lubicz, MD (1) · Edoardo Boccardi, MD (1) · J. Thomas Megerian, MD (1) · J. Thomas Megerian, MD, PhD (1) · Jonathan Megerian, MD, PhD (1) · Jonathan T Megerian, MD (1) · Masatsune Ishikawa, M.D. (1) · Michael Ward, DVM (1) · Paul Steinbok, MBBS, FRCSC (1) · Pedro Lylyk, MD (1) · Sean Lilienfeld, MD (1)
PMID 17476494, PMID 20871445, PMID 21040519, PMID 21611722, PMID 22239832, PMID 25803346, PMID 28251346, PMID 34795635