Clinical trials: Carotid Stenting
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
Carotid Artery Stenosis
Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting
The objective of this pivotal study is to evaluate the safety and efficacy of the CGuard™ Carotid Stent System in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery…
- Trial name
- C-Guardians (NCT04900844)
- Testing
- CGuard Carotid Stent implantation
- Where
- 18 sites in United States, Poland
- Volunteers
- 317 people
- Sponsor
- InspireMD
Carotid Artery Disease
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of…
- Trial name
- NCT00231231
- Testing
- -PRECISE Nitinol Stent System (5F, 5.5F and 6F), ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)
- Where
- United States
- Volunteers
- 1,500 people
- Sponsor
- Cordis US Corp.
Carotid Artery Stenosis, Carotid Artery Diseases
Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System
A prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP System for the treatment of carotid artery stenosis in subjects at elevated risk for adverse events following…
- Conditions
- Carotid Artery Stenosis, Carotid Artery Diseases, Carotid Stenosis
- Trial name
- PERFORMANCE II (NCT04201132)
- Testing
- Carotid artery stenting with Neuroguard IEP System
- Where
- 38 sites in United States, Bulgaria and 4 more
- Volunteers
- 305 people
- Sponsor
- Contego Medical, Inc.
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 Disease, Carotid Stenosis
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System when used under…
- Conditions
- Carotid Artery Disease, Carotid Stenosis, Stroke, Atherosclerosis
- Trial name
- NCT00287508
- Testing
- Carotid artery stenting with filter (interventional)
- Volunteers
- 1,500 people
- Sponsor
- Abbott Medical Devices
Carotid Artery Diseases
A Single-arm, Pivotal Study to Evaluate Acute Device and Technical Success of the CGuard Prime Carotid Stent System When Used in Conjunction to the ENROUTE Transcarotid Neuroprotection System in Patients Undergoing Carotid Artery Stenting Via the Transcarotid Artery Revascularization Approach
The objective of this study is to evaluate acute device and technical success of the CGuard Prime™ Carotid Stent System (80cm) when used in conjunction with the Enroute NPS during Transcarotid Artery Revascularization procedures…
- Trial name
- NCT06653387
- Testing
- CGuard Prime 80cm stent system
- Where
- 8 sites in United States
- Volunteers
- 50 people
- Sponsor
- InspireMD
Carotid Artery Disease
CAPTURE 2 Post-Marketing Registry
The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide…
- Trial name
- CAPTURE 2 (NCT00302237)
- Testing
- RX ACCULINK, RX ACCUNET Embolic Protection System
- Where
- United States
- Volunteers
- 6,426 people
- Sponsor
- Abbott Medical Devices
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 Atherosclerosis, Carotid Artery Disease
ACCULINK for Revascularization of Carotids in High Risk Patients "The ARCHeR Trial"
1. To evaluate the safety and efficacy of the over-the-wire (OTW) ACCULINK (tm) System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA) 2.
- Trial name
- NCT00180518
- Testing
- Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system
- Volunteers
- 581 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 Disease, Stroke Prevention
Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device.
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging…
- Trial name
- DESERVE (NCT00798512)
- Testing
- Carotid artery stenting
- Where
- 6 sites in Germany, Italy and 1 more
- Volunteers
- 127 people
- Sponsor
- Invatec S.p.A.
Carotid Artery Stenosis
EPIC US Feasibility Study: Use of the FiberNet® Emboli Protection Device in Carotid Artery Stenting
Multicenter, prospective, feasibility study designed to demonstrate the performance and safety of the Lumen Biomedical, Inc. FiberNet™ Embolic Protection System as an adjunctive device during carotid artery percutaneous…
- Trial name
- NCT00346515
- Testing
- FiberNet Emboli Protection System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Lumen Biomedical
Carotid Artery Stenosis
Evaluation of the Roadsaver Stent Used in Conjunction With the Nanoparasol Embolic Protection System for Carotid Artery Stenosis
A prospective, multicenter, single-arm, open label clinical study to evaluate the safety and effectiveness of MicroVention, Inc.
- Trial name
- NCT02657707
- Testing
- Roadsaver™ Carotid Artery Stent Device, Nanoparasol® Embolic Protection System
- Where
- 37 sites in United States
- Volunteers
- 295 people
- Sponsor
- Microvention-Terumo, Inc.
Carotid Stenosis, Carotid Artery Diseases
Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
The PERFORMANCE III study is a prospective, multicenter single-arm, open label study to evaluate the safety and effectiveness of the Neuroguard IEP® Direct System for the treatment of carotid artery stenosis in subjects at…
- Trial name
- NCT05845710
- Testing
- Neuroguard IEP Direct System
- Where
- 32 sites in United States, France
- Volunteers
- 178 people
- Sponsor
- Contego Medical, Inc.
Carotid Artery Disease
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)
The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of…
- Trial name
- NCT00231270
- Testing
- Cordis Nitinol Stent, PRECISE tapered stent, ANGIOGUARD XP Emboli Capture Guidewire (ECGW)
- Volunteers
- 1,300 people
- Sponsor
- Cordis US Corp.
Carotid Artery Stenosis
CGUARDIANS III IDE Pivotal Trial
This is a prospective, multi-center, single-arm, pivotal study. The objective of this study is to evaluate the safety and efficacy of the SwitchGuard NPS in providing cerebral embolic protection during Transcarotid Artery…
- Trial name
- NCT07277296
- Testing
- SwitchGuardTM NPS
- Volunteers
- 103 people
- Sponsor
- InspireMD
Percutaneous Intervention of the Carotid Arteries.
EPIC US Pivotal Study
Multicenter, prospective, pivotal study designed to demonstrate the safety and efficacy of the Lumen Biomedical, Inc. FiberNet® Embolic Protection System as an adjunctive device during carotid artery percutaneous intervention in…
- Trial name
- EPIC (NCT00460187)
- Testing
- Percutaneous intervention of the carotid artery
- Where
- 2 sites in United States
- Volunteers
- 237 people
- Sponsor
- Lumen Biomedical