Clinical trials: Carotid Stenoses
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
Gadobutrol Enhanced MRA of the Supra-aortic Vessels
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days.
- Trial name
- GEMSAV (NCT01344447)
- Testing
- Gadobutrol (Gadovist, BAY86-4875)
- Where
- 56 sites in United States, Argentina and 12 more
- Volunteers
- 479 people
- Sponsor
- Bayer
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 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 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 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 Stenosis, Constriction, Pathologic
GORE Flow Reversal System and GORE Embolic Filter Extension Study
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders
- Trial name
- FREEDOM (NCT01343667)
- Testing
- Gore Flow Reversal System, Gore Embolic Filter
- Where
- 39 sites in United States
- Volunteers
- 1,397 people
- Sponsor
- W.L.Gore & Associates
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 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 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
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 Plaque
99mTc-rhAnnexin V-128 Imaging for Carotid Atherosclerosis
This was a single-center, single-dose, study comprising a Proof of Concept (PoC) part and a subsequent Phase II part. The study was being done to assess the ability of the radiotracer 99mTc-rhAnnexin V-128 to image…
- Trial name
- NCT02667457
- Testing
- 99mTc-rhAnnexin V-128
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Advanced Accelerator Applications
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 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
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