Clinical trials: Artery Stenosis, Carotid
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
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 Diseases, Stroke
Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be…
- Conditions
- Carotid Artery Diseases, Stroke, Cerebral Arteriosclerosis
- Trial name
- BEACH (NCT00316108)
- Testing
- WALLSTENT® Endoprosthesis™
- Where
- 50 sites in United States
- Volunteers
- 747 people
- Sponsor
- Boston Scientific Corporation
Internal Carotid Artery Stenosis
MICHI™ Neuroprotection System (NPS+f) Filter Debris Analysis Study (The F-1 Study)
This study will be conducted in up to 10 hospitals in Europe, up to 75 patients will be enrolled. The purpose of the study is to evaluate any debris that may be captured in the inline filter of the MICHI(TM) Neuroprotection…
- Trial name
- NCT01877174
- Testing
- MICHI(TM) NPS+f, transcarotid stenting
- Where
- 6 sites in Belgium, Germany and 1 more
- Volunteers
- 24 people
- Sponsor
- Silk Road Medical
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
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 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 Artery Disease, Symptomatic Carotid Artery Stenosis
High Coverage CARotid Stenting vs. Medical Management Alone to Prevent EmboliSm From symptomaTic Non-stenotic cARotid Disease (SyNC)
Goal is to analyse the clinical safety and efficacy of the CARESTO® heal Stent within standard clinical routine for the treatment of patients with symptomatic non-stenotic carotid disease (SyNC) and with high-risk plaque features…
- Conditions
- Carotid Artery Disease, Symptomatic Carotid Artery Stenosis, Carotid Artery Stenting, Carotid Plaque Imaging
- Trial name
- CARESTAR (NCT07166731)
- Where
- Germany
- Volunteers
- 536 people
- Sponsor
- Acandis GmbH
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 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 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 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
Atherosclerosis
Study Effect of VIA-2291 on Atherosclerotic Vascular Inflammation in Patients Undergoing Elective Carotid Endarterectomy
This is a study to compare the effect of VIA-2291 vs. Placebo on various inflammatory biomarkers in patients with carotid stenosis scheduled for elective carotid endarterectomy
- Trial name
- NCT00352417
- Testing
- VIA-2291
- Where
- 3 sites in Italy
- Volunteers
- 50 people
- Sponsor
- Tallikut Pharmaceuticals, Inc.
Carotid Artery Diseases, Carotid Atherosclerosis
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.
- Conditions
- Carotid Artery Diseases, Carotid Atherosclerosis, Carotid Stenosis, Carotid Artery Plaque
- Trial name
- DW-MRI-US (NCT03982420)
- Testing
- Transcarotid Revascularization (TCAR)
- Where
- 6 sites in United States, Spain
- Volunteers
- 55 people
- Sponsor
- Silk Road Medical
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 Stenosis
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
The goal of this observational study is to learn whether continuous carotid artery blood flow signals can be recorded reliably during surgery, and whether Vibrant Medical's analysis method can detect measurable changes in those…
- Trial name
- NCT07851389
- Testing
- Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vibrant Medical Ltd.
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 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
Femoral Artery Stenosis, Iliac Artery Stenosis
Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine
Uni-Graft® K DV Patch is marketed in Europe since 1999 for reconstructive interventions of the deep femoral, femoral and iliac artery and was also indicated for carotid interventions until 01/2020.
- Conditions
- Femoral Artery Stenosis, Iliac Artery Stenosis, Carotid Artery Stenosis
- Trial name
- RESTUGPA (NCT05117515)
- Testing
- Vascular reconstruction
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
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.