Clinical trials: Carotid Artery Stenoses
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
Hyperlipidemias, Atherosclerosis
Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy.
- Conditions
- Hyperlipidemias, Atherosclerosis, Coronary Heart Disease, Carotid Stenosis
- Trial name
- NCT00536965
- Where
- Austria
- Volunteers
- 951 people
- Sponsor
- AstraZeneca
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 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
Carotid Stenosis, Carotid Artery Diseases
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Study
The goal of this study is to evaluate the incidence of post procedure DW-MRI lesions (relative to baseline) and debris captured in the ENROUTE Transcarotid NPS inline filter during a transcarotid stenting procedure.
- Conditions
- Carotid Stenosis, Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Artery Plaque
- Trial name
- DW-MRI OUS (NCT03985774)
- Testing
- Transcarotid revascularization
- Where
- 3 sites in Belgium, Germany and 1 more
- Volunteers
- 31 people
- Sponsor
- Silk Road Medical
Artery Stenosis, Carotid, Artery Stenosis
A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.
- Conditions
- Artery Stenosis, Carotid, Artery Stenosis, Occlusion of Artery, Stroke
- Trial name
- NCT04643743
- Testing
- Endarterectomy
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Perouse Medical
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 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
Carotid Artery Stenosis
Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.
- Trial name
- NCT03816202
- Testing
- Sundt carotid shunt
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Carotid Artery Stenosis
Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis
The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis.
- Trial name
- NCT06365697
- Testing
- Ton-bridge carotid stent, WALLSTENT carotid stent
- Where
- 7 sites in China
- Volunteers
- 188 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
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
Intracranial Embolism, Cerebral Thromboembolism
Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
The purpose of this study is to determine, in patients undergoing carotid endarterectomy, the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler immediately after surgery.
- Conditions
- Intracranial Embolism, Cerebral Thromboembolism, Carotid Stenosis
- Trial name
- NCT00742612
- Testing
- ARC1779 Injection
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Archemix Corp.
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 Stenosis
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for…
- Trial name
- NCT00395785
- Testing
- Carotid Stent Implantation, Embolic Protection
- Where
- 34 sites in United States, Germany
- Volunteers
- 400 people
- Sponsor
- Kensey Nash Corporation
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 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 Stenosis, Atherosclerosis
Revacept in Symptomatic Carotid Stenosis
Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet monotherapy or monotherapy alone.
- Conditions
- Carotid Stenosis, Atherosclerosis, Stroke, Transient-ischaemic Attack
- Trial name
- RevaceptCS02 (NCT01645306)
- Testing
- Revacept
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 158 people
- Sponsor
- AdvanceCor GmbH
Carotid Artery Stenoses
A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.
- Trial name
- NCT02501148
- Testing
- carotid artery stenting
- Where
- 5 sites in Germany
- Volunteers
- 106 people
- Sponsor
- Contego Medical, Inc.
Carotid Artery Stenosis
Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)
Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.
- Trial name
- NCT06936189
- Where
- China
- Volunteers
- 204 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Carotid Artery Stenosis
PMCF Study of Precise Pro Rx for Carotid Artery Disease
The purpose of this study is to evaluate long-term clinical safety and performance of the PRECISE PRO RX Nitinol Stent System to treat stenotic lesions of the carotid arteries.
- Trial name
- REAL-PRECISE (NCT07204678)
- Testing
- PRECISE PRO Rx Nitinol Stent System
- Where
- 4 sites in Austria, France and 1 more
- Volunteers
- 199 people
- Sponsor
- Cordis US Corp.