Clinical trials: Carotid Stenting
Carotid Artery Disease
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
The purpose of this study is to obtain and establish the safety and efficacy of The MICHI™ Neuroprotection System with Filter (MICHI™ NPS+f) for providing cerebral embolic protection during angioplasty and stenting procedures in…
- Trial name
- ROADSTER (NCT01685567)
- Testing
- MICHI NPS+f
- Where
- 21 sites in United States, Spain
- Volunteers
- 219 people
- Sponsor
- Silk Road Medical
Carotid Artery Disease
A Carotid Stenting Boston Scientific Surveillance Program
CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the…
- Trial name
- CABANA (NCT00741091)
- Testing
- Carotid WALLSTENT Monorail Endoprosthesis, FilterWire EZ™ System™
- Where
- 112 sites in United States
- Volunteers
- 1,097 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Disease
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and…
- Trial name
- PROTECT (NCT00402740)
- Testing
- Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
- Where
- 38 sites in United States
- Volunteers
- 322 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Disease, Carotid Artery Stenosis
The Gore SCAFFOLD Clinical Study
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
- Trial name
- NCT01901874
- Testing
- Carotid Artery Stenting
- Where
- 2 sites in United States
- Volunteers
- 312 people
- Sponsor
- W.L.Gore & Associates
Carotid Artery Disease, Carotid Stenosis
Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)
The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the…
- Conditions
- Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
- Trial name
- ACT I (NCT00106938)
- Testing
- Carotid artery stenting with filter (interventional), Carotid artery endarterectomy (surgical)
- Where
- 62 sites in United States
- Volunteers
- 1,663 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Stenosis
Protective Effects of Long-term Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Remote limb ischemic preconditioning (RIPC) has neuro-protective and anti-inflammatory effects on ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum…
- Trial name
- NCT01654666
- Testing
- Remote ischemic preconditioning, Carotid Artery Stenting
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Ji Xunming
Carotid Stenosis
Post-Approval Study of the NexStent Carotid Stent System and the FilterWire EZ Embolic Protection System: SONOMA
The primary objective of the SONOMA Registry is to confirm the safety of the NexStent® Carotid Stent System and FilterWire EZ™ Embolic Protection System in routine clinical practice and to identify rare or unanticipated…
- Trial name
- SONOMA (NCT00478673)
- Testing
- NexStent Carotid Stent System (Monorail Delivery System), FilterWire EZ™ Embolic Protection System
- Where
- 62 sites in United States
- Volunteers
- 298 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Disease
Proximal Protection With The Mo.Ma Device During Carotid Stenting
The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery…
- Trial name
- ARMOUR (NCT00744523)
- Testing
- Mo.Ma cerebral protection device
- Where
- 2 sites in United States
- Volunteers
- 262 people
- Sponsor
- Medtronic Endovascular
Internal Carotid Artery Stenosis
SONOlysis in Prevention of Brain Infarctions dUring Carotid Stenting and caroTid EndaRterectomy
The aim of the project is to demonstrate a fibrinolytic effect of sonothrombolysis (continual transcranial Doppler monitoring) using 2 MegaHertz (MHz) diagnostic probe on the reduction of risk of brain infarctions due to the…
- Trial name
- SONOBUSTER (NCT01591005)
- Testing
- sonolysis, endarterectomy, carotid stenting
- Where
- Czechia
- Volunteers
- 242 people
- Sponsor
- University Hospital Ostrava
Carotid Stenosis, Carotid Artery Disease
The MICHI NEUROPROTECTION SYSTEM: Evaluation of Performance in Carotid Artery Stent Procedures (The LOTUS Study)
The LOTUS Study is intended to demonstrate the usability of the MICHI Neuroprotection System (MICHI NPS) or MICHI Neuroprotection System with filter (MICHI NPS+f) for use in subjects who are candidates for Carotid Artery Stenting…
- Trial name
- LOTUS (NCT01958294)
- Testing
- MICHI Neuroprotection System
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- Silk Road Medical
Carotid Artery Diseases
Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the…
- Trial name
- PROOF (NCT01264419)
- Testing
- Silk Road Embolic Protection System
- Where
- Germany
- Volunteers
- 75 people
- Sponsor
- Silk Road Medical
Atherosclerosis, Stroke
Carotid Revascularization Endarterectomy Versus Stenting Trial
The purpose of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) is to compare the relatively new procedure of stent-assisted carotid angioplasty (CAS) to the traditional and accepted surgical approach of…
- Conditions
- Atherosclerosis, Stroke, Carotid Stenosis, Cerebral Infarction
- Trial name
- CREST (NCT00004732)
- Testing
- Carotid Endarterectomy (CEA), Carotid Artery Stenting (CAS)
- Where
- 115 sites in United States, Canada
- Volunteers
- 2,502 people
- Sponsor
- Rutgers, The State University of New Jersey
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Carotid Artery Stenosis
ViVEXX Carotid Revascularization Trial (VIVA)
To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid…
- Trial name
- NCT00417963
- Testing
- Carotid Artery Stenting
- Volunteers
- 407 people
- Sponsor
- C. R. Bard
Carotid Artery Disease, Stroke
Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy
The objective of the CANOPY trial is to assess the continued safety and effectiveness of the RX Acculink Carotid Stent System under commercial use in subjects at standard risk for adverse events from Carotid Endarterectomy (CEA)…
- Conditions
- Carotid Artery Disease, Stroke, Amaurosis Fugax, Transient Ischemic Attack (TIA)
- Trial name
- CANOPY (NCT01445613)
- Testing
- RX Acculink Carotid Stent System (RX Acculink)
- Where
- United States
- Volunteers
- 1,203 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Diseases, Stroke
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery Stenting
The purpose of this study is to compare the safety and performance of WIRION™ EPD in patients undergoing carotid artery stenting to a performance goal based on an analysis of the results of previous US IDE carotid stenting with…
- Trial name
- WISE (NCT01783639)
- Testing
- Carotid Artery Stent
- Where
- 10 sites in Belgium, Germany and 1 more
- Volunteers
- 120 people
- Sponsor
- Gardia Medical
Carotid Artery Stenosis
GORE Embolic Protection With Reverse Flow
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
- Trial name
- EMPiRE (NCT00594100)
- Testing
- GORE Flow Reversal System (GFRS)
- Where
- 2 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Stroke, Carotid Stenosis
Effects of Carotid Stent Design on Cerebral Embolization
The goal of the proposed study is to contrast the relative efficacy of closed-cell stents versus open-cell stents in preventing periprocedural cerebral embolization in high-risk patients with symptomatic and asymptomatic…
- Trial name
- NCT00830232
- Testing
- closed-cell stent (Xact stent), Open-cell stent (Acculink carotid)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Dallas VA Medical Center