Clinical trials: Carotid Endarterectomy
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
SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy
The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease.
- Trial name
- NCT00403078
- Where
- 5 sites in United States
- Volunteers
- 21,008 people
- Sponsor
- Cordis US Corp.
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 Atherosclerosis
Merck Carotid Atherosclerosis Trial (MK-0000-111)(COMPLETED)
This study will examine the effect of statin and niacin therapy on carotid plaque biomarkers
- Trial name
- MCAT (NCT00804843)
- Testing
- Atorvastatin/niacin extended-release, Atorvastatin, Simvastatin
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
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
Stroke
Validation of Neurokeeper's Algorithm on Patients Undergoing Carotid Endarterectomy
The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing Carotid…
- Trial name
- NCT01737736
- Testing
- Neurokeeper stroke detector
- Where
- Israel
- Sponsor
- Neurokeeper Technologies
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 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
Hemodynamic Stability
Hemodynamic Stability During Carotid Endarterectomy.Comparison of LENOXe™ (Xenon 100% v/v) Versus Sevoflurane
The purpose of this study is to compare the hemodynamics effects of two usual hypnotic agents (LENOXe ™ (xenon 100 % v/v) and sevoflurane) during a general anesthesia for carotid endarterectomy in elderly patients.
- Trial name
- NCT00937807
- Testing
- xenon, sévoflurane
- Where
- France
- Volunteers
- 84 people
- Sponsor
- Air Liquide Santé International
Carotid Stenosis
CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
Assess device performance data from subjects undergoing patch angioplasty of the carotid artery following carotid endarterectomy using the CorMatrix ECM for Carotid Repair.
- Trial name
- NCT01569594
- Testing
- CorMatrix ECM for Carotid Repair
- Where
- 6 sites in United States
- Volunteers
- 230 people
- Sponsor
- Elutia Inc.
Carotid Stenosis
[F-18] RGD-K5 Positron Emission Tomography (PET) in Participants With Carotid Artery Stenosis
This trial will be the first trial for the Investigation Product (IP), [F-18]RGD-K5 for carotid plaque imaging and will be conducted as a Phase II trial since this compound has already been tested in humans for phase I and phase…
- Trial name
- NCT01602471
- Testing
- [F-18]RDG-K5
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Siemens Molecular Imaging
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
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 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
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, 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
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 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.
Atherosclerosis
Study to Determine the Effect of 14 Days Dosing With Darapladib (SB-480848) on Carotid Plague Composition in Patients With Planned Carotid Endarterectomy
The primary objective is to determine Lp-PLA2 activity in atherosclerotic carotid plaques after 14 (+/-4) days treatment with darapladib, compared to placebo.
- Trial name
- NCT01916720
- Testing
- SB-480848 40 mg, SB-480848 80 mg
- Volunteers
- 103 people
- Sponsor
- GlaxoSmithKline