Clinical trials: Carotid Artery Stenting
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
Comparison of Staged Angioplasty and Routine Single-stage Stenting (CAS) in the Treatment of Carotid Artery Stenosis
The purpose of this study is to evaluate the efficacy and safety of staged carotid angioplasty v.s. routine single-stage carotid artery stenting in Chinese patients with carotid artery stenosis at high hyperperfusion risk in…
- Trial name
- STEP (NCT02224209)
- Testing
- Abbott EPD systems (Accunet/Emboshield), a balloon, stent, a balloon, stent
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Beijing Tiantan Hospital
Carotid Stenosis
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in…
- Trial name
- CREST-2 (NCT02089217)
- Testing
- Carotid endarterectomy (CEA), Carotid Stenting (CAS), Intensive Medical Management - no CEA
- Where
- 167 sites in United States, Australia and 3 more
- Volunteers
- 2,486 people
- Sponsor
- Mayo Clinic
Identify the Presence of a Marker of Ischemia/Hypoperfusion of the Brain Via Peripheral Blood, Ischemia/Hypoperfusion of Brain
Biomarkers of Ischemia: Xanthine, Hypoxanthine and Inosine Levels During Carotid Stenting Procedures
The purpose of the study is to determine if a new blood test can help the doctor determine if there is brain injury or ischemia. Ischemia occurs when not enough oxygen gets to the brain.
- Trial name
- NCT01639534
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Virginia Commonwealth University
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 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 Diseases
OPTIMAl Endovascular Exclusion of Consecutive Patient High-risk Carotid Plaque Using the MicroNet Covered Stent
Prospective, multicentric, multispecialty, international, open-label, single arm study using per-protocol intravascular ultrasound [IVUS, 20MHz electronic phase-array transducer] to document the procedure result of an effective…
- Trial name
- OPTIMA (NCT04234854)
- Testing
- Intravascular Utrasound (IVUS) of Carotid Artery after implantation of CGuard stent
- Where
- Poland
- Volunteers
- 200 people
- Sponsor
- John Paul II Hospital, Krakow
Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%)
The SIBERIA Trial (Acculink™ Versus CGuard™)
That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards
- Conditions
- Patients With Aterosclerotic Carotid Stenosis, Symptomatic Patients (Stenosis > 50%), Asymptomatic Patients (Stenosis ≥80%)
- Trial name
- CAS (NCT03488199)
- Testing
- Stent Acculink ™, CGuardTM™
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation
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 Stenosis, Coronary Artery Disease
Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart…
- Conditions
- Carotid Stenosis, Coronary Artery Disease, Valvular Heart Disease, Myocardial Infarction
- Trial name
- SIM-GUARD (NCT04973579)
- Testing
- Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- John Paul II Hospital, Krakow
Stroke, TIA
The Effect Of Remote Limb Ischemic Preconditioning For Carotid Artery Stenting
Remote limb ischemic preconditioning is neuro-protective and anti-inflammatory for ischemia- reperfusion injury. As the extent of its effect is unknown, the investigators will use clinical outcome, serum biochemical markers and…
- Conditions
- Stroke, TIA, Coronary Stenosis
- Trial name
- NCT01175876
- Testing
- remote limb ischemic preconditioning, Carotid Artery Stenting
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Capital Medical University
Carotid Stenosis
Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection.
Stenting is an alternative to traditional surgery in the treatment of carotid stenosis.The intra and/or postprocedural cerebral embolization remains the most frequent complication.
- Trial name
- NCT02915328
- Testing
- Filterwire EZ™, MO.MA Ultra, Stent Roadsaver®
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Centro Cardiologico Monzino
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
Carotid Stenosis, Ischemia Reperfusion Injury
Perioperative Time Course of MMP-9 and Its Inhibitor During Carotid Artery Stenting and Carotid Endarterectomy
The aim was the comparison of the perioperative time courses of matrix metalloproteinase-9 (MMP-9) and its inhibitor (TIMP-1) during elective carotid artery stenting (CAS).
- Trial name
- NCT03410576
- Testing
- Carotid artery stenting, Carotid endarterectomy
- Where
- Hungary
- Volunteers
- 25 people
- Sponsor
- University of Pecs
Carotid Artery Diseases
Digital Variance Angiography for Contrast Media Dose Reduction in Carotid Artery Stenting
Digital Variance Angiography (DVA) is a new tool in medical imaging with a proven image quality reserve (1, 2). Previous studies have demonstrated the quality reserve of DVA in angiographic studies (1, 2), which allowed us to…
- Trial name
- NCT04792255
- Testing
- Carotid artery stenting with standard contrast media protocol, Carotid artery stenting with reduced contrast media protocol, Carotid Duplex Ultrasound
- Where
- Hungary
- Volunteers
- 100 people
- Sponsor
- Kinepict Health Ltd.
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
Acute Ischemic Stroke
An EFS to Evaluate the CGuard Prime™ Carotid Stent in Acute Ischemic Stroke
The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an…
- Trial name
- NCT06447116
- Testing
- CGuard Prime™ Carotid Stent System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Jacobs institute