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Carotid Artery Stenosis clinical trials

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NCT ID: NCT05126238 Recruiting - Clinical trials for Carotid Artery Diseases

A Lithium-Based Medication to Improve Neurological Outcomes After Surgical Carotid Reconstruction

Start date: November 20, 2021
Phase: Phase 3
Study type: Interventional

There are 10.3 million cases of stroke registered in the world every year; 63% of them lead to death. According to World Health Organization, stroke is one of the most important risk factors of death and early disability. Carotid artery surgery is a gold standard of hemodynamically significant carotid artery disease treatment. According to some trials, carotid artery surgery decreases the 2-years mortality. The most important part of carotid artery surgery is a temporary absence of blood flow in the carotid artery. The duration of this period is a crucial characteristic of this type of surgery. The absence of blood flow leads to brain ischemia which is the risk factor of postoperative neurocognitive disorders such as emergence delirium, postoperative delirium and postoperative cognitive dysfunction. Some surgical and non-surgical methods for brain protection were evaluated. According to recent data, there is no evidence of effective pharmacological protective methods that can decrease brain damage during carotid artery surgery. Nevertheless, some trials demonstrated that using lithium-based medications for patients with a stroke can reduce the volume of the stroke. Therefore, the investigators want to check the hypothesis that using lithium-based medication in the preoperative period can reduce brain damage during carotid artery surgery. The objectives of this trial: 1. To determine if Lithium carbonate is superior to placebo for the occurrence of emergence delirium, agitation, postoperative delirium and postoperative cognitive dysfunction. 2. To determine if Lithium carbonate is non-inferior to placebo for the occurrence of a new arrhythmia, leukocytosis, acute kidney injury, seizure disorders, diarrhea, nausea, and vomit.

NCT ID: NCT05117515 Enrolling by invitation - Clinical trials for Carotid Artery Stenosis

Retrospective Study of the Uni-Graft® K DV Patch in the Clinical Routine

RESTUGPA
Start date: April 27, 2022
Phase:
Study type: Observational

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. Previous studies focused on the clinical performance of different patch materials used for patch angioplasty in different indications, without specifying the product or manufacturer. Thus, it is not surprising that there is a limited amount of published literature available describing the use of the Uni-Graft® K DV Patch in the clinical routine. Therefore, the aim of the present non-interventional study (NIS) is to close this gap by collecting and evaluating existing safety and performance data documented in the clinical routine especially during the application of the Uni-Graft® K DV Patch.

NCT ID: NCT04900844 Recruiting - Clinical trials for Carotid Artery Stenosis

Safety and Efficacy of the CGuard™ Carotid Stent System in Carotid Artery Stenting

C-Guardians
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

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 stenting (CAS) to a performance goal developed from published CAS literature.

NCT ID: NCT04759859 Withdrawn - Clinical trials for Carotid Artery Stenosis

Neuropsychological Functioning and Cerebral Perfusion Post Carotid Endarterectomy

Start date: January 22, 2013
Phase:
Study type: Observational

The study aims to investigate the relationship between neuropsychological functioning and brain perfusion in patients undergoing carotid endarterectomy and control patients undergoing other peripheral vascular procedures.

NCT ID: NCT04651998 Recruiting - Clinical trials for Carotid Artery Stenosis

Effect of Carotid Artery Stent on Evoked Cerebral Blood Oxygenation and Neurocognitive Functioning

Start date: May 1, 2021
Phase:
Study type: Observational [Patient Registry]

Cerebral hemodynamic compromise from internal carotid artery stenosis may be a cause of vascular cognitive impairment that is amenable to treatment by revascularization. The effect of carotid artery stent on evoked cerebral blood oxygenation and neurocognitive functioning will be evaluated by functional near-infrared spectroscopy. Carotid artery stent could benefit cerebral blood oxygenation after stent and improving neurocognitive functioning after 6 months.

NCT ID: NCT04539223 Recruiting - Clinical trials for Carotid Artery Stenosis

A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy

SLICE-CEA
Start date: August 28, 2020
Phase: Phase 4
Study type: Interventional

This is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive LDL-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.

NCT ID: NCT04201132 Active, not recruiting - Carotid Stenosis Clinical Trials

Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System

PERFORMANCE II
Start date: June 12, 2020
Phase: N/A
Study type: Interventional

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 carotid endarterectomy (CEA).

NCT ID: NCT04142541 Completed - Clinical trials for Carotid Artery Stenosis

Evaluation of the 3-in-1 Neuroguard IEP System for Carotid Artery Stenosis

PERFORMANCE
Start date: February 28, 2018
Phase: N/A
Study type: Interventional

The Neuroguard IEP System is a 3-in-1 carotid stent delivery system consisting of an angioplasty balloon, an integrated embolic protection device and a nitinol self-expanding stent loaded over the balloon and constrained by an outer sheath. The PERFORMANCE I study is a multi-center, prospective, single arm open label study to evaluate the safety and feasibility of the Neuroguard IEP System for the treatment of carotid artery stenosis. The primary endpoint will be the proportion of patients with Major Adverse Events (MAE) reported within 30 days from the index procedure. The primary objective of the PERFORMANCE I study is to evaluate the safety and feasibility of the Neuroguard IEP Carotid Stent System when used in patients with clinically significant carotid artery stenosis requiring revascularization.

NCT ID: NCT04098523 Completed - Clinical trials for Abdominal Aortic Aneurysm

Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study.

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Both abdominal aortic aneurysm (AAA) and carotid artery stenosis (CAS) are frequent clinical entities, with major morbidity and mortality. This project obtains robust data on the prevalence of AAA and CAS in the Brussels Capital Region. Using duplex ultrasound, a low invasive examination, we want to obtain information on a vast sample of men and women of the Brussels capital region, starting at the age of 60. With these data we can have a far better view on the Belgian situation of these two main vascular clinical entities. The data can provide insights on if, and how, Belgian public health policy can be improved concerning AAA and CAS.

NCT ID: NCT03996148 Completed - Clinical trials for Carotid Artery Stenosis

Time to Post-Anesthesia Neurological Evaluation With Three Different Anesthetic Techniques

Start date: September 29, 2017
Phase: Phase 4
Study type: Interventional

The objective of this pilot study is to analyze the differences in time to first postoperative neurological examination (cranial nerve XII - tongue movement, movement of extremities) and intraoperative hemodynamic stability with three different general anesthetic techniques that are used for carotid endarterectomy. Carotid endarterectomy surgery removes the plaque and stenosis but has a 1-3% risk of periprocedural stroke or death. The ability to detect neurological abnormalities early after surgery is vital in this patient population to facilitate timely additional diagnostics or interventions if a potential stroke is detected. Anesthetic techniques that facilitate an earlier reliable neurological exam will thus greatly benefit this surgical patient population. The primary objective of this pilot study is to determine the time difference from end of surgery to first neurologic exam between three commonly used anesthetic methods for carotid endareterectomy.