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Showing 1-19 of 19 trials
NCT07322913
The purpose of this registry is to evaluate the long-term safety and performance of Intervascular Vascular Grafts and Patches (Intergard Standard, Hemashield, Intergard Silver, Intergard Synergy) for bypass, repair or replacement of aortic, peripheral, or carotid arteries. This registry is intended to further define the expected product lifetime of the devices and to collect data related to usefulness of the antimicrobial coatings.
NCT05845710
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 elevated risk for carotid endarterectomy (CEA). Eligible patients greater than or equal to 20 years of age and less than or equal to 82 years of age, are those who have been diagnosed with either de-novo atherosclerotic or post CEA restenotic lesion(s) in the internal carotid arteries (ICA) or at the carotid bifurcation with greater than or equal to 50% stenosis if symptomatic or greater than or equal to 70% stenosis if asymptomatic.
NCT05720156
Cardiovascular disease (CVD) represents the leading cause of death worldwide. While medications, such as statins, significantly reduce atherosclerotic CVD (ASCVD) risk by lowering low density lipoprotein levels, they may also have pleiotropic effects on inflammation. The immunomodulatory effects of these medications are relevant to ASCVD risk reduction given that inflammation plays a central role in atherosclerotic plaque formation (atherogenesis) and influences the development of vulnerable plaque morphology. Patients on statins, however, may have residual inflammation contributing to incident ASCVD despite the potent LDL-lowering effects of statins. While new therapies, such as proprotein convertase subtilisin/kexin type 9 (PSCK9) inhibitors, further reduce incident ASCVD and drastically reduce LDL-C below that achieved by statin therapy alone, PCSK9 inhibitors may also have pleiotropic effects on inflammation. Thus, PCSK9 inhibitors may help reduce arterial inflammation to a level closer to that of patients without ASCVD. This study will apply a novel targeted molecular imaging approach, technetium 99m (99mTc)-tilmanocept SPECT/CT, to determine if residual macrophage-specific arterial inflammation is present with statin therapy and the immunomodulatory effects of PSCK9 inhibition. Given the continued high mortality and morbidity attributable to ASCVD, strong imperatives exist to better understand the immunomodulatory effects of lipid lowering therapies and residual inflammatory risk. This understanding, in turn, will inform the development of new ASCVD preventative and treatment strategies as well as elucidate other indications for established therapies.
NCT07062471
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries prior to Trans-Carotid Stenting (SKYWARD Trans-Carotid IDE Study)
NCT06653387
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 in the treatment of carotid artery stenosis in spatients at high risk for adverse events from carotid endarterectomy.
NCT06211725
Stroke is the second leading cause of death and the third leading cause of disability worldwide. The cause is usually either a blockage or a severe narrowing of a cerebral artery. An important part of stroke prevention is the diagnosis and clarification of stenosis in the arteries supplying the brain, both inside and outside the skull, in order to diagnose a high-grade stenosis at an early stage and offer the patient revascularization. In particular, asymptomatic carotid artery stenosis confronts the diagnosing physician with the question of whether revascularisation is necessary. Risk factors for stroke in asymptomatic carotid artery stenosis include contralateral TIA or cerebral infarction, male gender, rapid progression of the degree of stenosis, plaque morphology, clinically silent cerebral infarctions, Doppler sonographic evidence of microemboli or reduced vasomotor reserve. An established biomarker does not exist at this time. A candidate for such a biomarker in the blood is the protein \"neurofilament light chain\" (NFL), which is already established in the diagnosis of dementia. As a component of the cytoskeleton of neurons, it is released into the patient\'s blood when the cells are damaged and can be measured there. Another candidate is glial fibrillary acid protein (GFAP), a part of the cytoskeleton of glial cells that is also released into the blood when glial cells are damaged. A systematic investigation of the value of neurofilament light chain and the glial fibrillary acidic protein in the blood of patients with asymptomatic carotid stenosis is still lacking. VANGAS determines the value of NFL and GFAP from the blood of patients with asymptomatic carotid stenosis to determine associations with the degree of stenosis, the natural course of the stenosis (increase or decrease) and possible symptoms of the stenosis as well as the functional outcome after symptomatic stenosis.
NCT06058507
In our research, we aim to increase awareness on this issue by classifying the frequency of carotid webs and their radiological classification; Evaluating the clinical data and vascular risk factors of carotid web cases and determining their relationship with ischemic stroke and determining the measures that can be taken for future optimal treatment. We aimed to contribute to their approach.
NCT05196685
This study will be carried out prospectively on patients who applied to the cardiovascular surgery polyclinic and the carotid-vertebral artery doppler ultrasound due to the vascular problem. All patients will fill "Balance Disorder Scan Survey" and "Vertigo-Dizziness Imbalance Questionnaire-SS". Patients who score 1 and more are directed to the ear nose throat polyclinic and detailed differential diagnosis. Those who score 0 will be in control group.
NCT04679727
Carotid artery disease is a main cause of ischemic stroke and vascular dementia, and a highly prevalent disease. There is uncertainty about the optimal management of patients with serendipitously or systematically detected asymptomatic carotid artery disease, due to the paucity of information on the predictive features of serious vascular events. While percent diameter stenosis is currently the accepted standard to decide about local interventions (carotid artery stenting or endarterectomy), international guidelines also recommend the evaluation of qualitative features of carotid artery disease as a guide to treatment. There is, however, no agreement on which qualitative features are best predictors of events. Furthermore, a role for metabolic plaque profile, local mechanical and hemorheologic factors in triggering microembolization and silent ischemic events has been proposed from experimental studies. This inadequate knowledge leads to a poor ability to identify patients at higher risk and to an unwarranted dispersion of medical resources, lack of standardization in diagnostic methods, and the use of expensive and resource-consuming techniques. Against this background, the investigators aim at: 1. Prospectively identifying the best predictors of (silent and overt) ischemic stroke and vascular dementia in patients with asymptomatic subcritical carotid artery disease, by identifying the non-invasive diagnostic features of the "vulnerable carotid plaque" as a possible guide for optimal - local and systemic - treatment. 2. Transferring new ultrasound techniques possibly improving risk prediction to the clinical field 3. Assess whether "smart", low-cost diagnostic methods, such as ultrasound-based evaluations integrating established and advanced techniques, may yield at least the same level of prospective information as more expensive and less cost-effective techniques.
NCT05539781
The majority (\>80%) of strokes are of ischemic etiology, of which ≈15% to 20% are attributable to atherosclerosis of the extracranial carotid arteries. The primary goal in carotid artery revascularization is to prevent stroke in patients with carotid artery stenosis. Treatment options including carotid endarterectomy (CEA) and carotid artery stenting (CAS). Hence, the investigators aim to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in terms of long-term prognostic endpoints. Also, CEA and CAS result in different postoperative geometric features of carotid arteries that entail relevant modifications of rheological parameters, that may be associated with the risk of local complications and carotid artery restenosis. Finally, long-term and sustained cognitive benefits after carotid artery revascularization need further research and evidence.
NCT04234854
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 plaque exclusion from the vessel lumen.
NCT03985774
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.
NCT03516929
From our experience among Egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. Thus, increasing the risk of post-operative morbid complications.We aim to evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a prospective, non-randomized, comparative study including two groups of patients. The study will start from the day of approval of the ethical committee. It will include 260 patients, on basis of "all new comers". Patients will be examined and classified as "high-risk" group (ɳ = 130) or "low-risk" group (ɳ=130). All patients will have the "routine" preoperative investigations along with evaluation of extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by non-invasive bilateral lower limb arterial duplex.
NCT01264419
Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed. Cerebral protection with carotid flow reversal is a method that was developed by Parodi, et al., as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Criado, et al., developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach. Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.
NCT03568032
Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT). The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).
NCT00005397
To examine the relationship of risk factors measured in childhood to intimal medial thickness (IMT) in early adulthood and to examine familial factors which may be related to increased IMT, a measure of atherosclerosis.
NCT02750644
Until the irruption of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), carotid stenting (CAS) has been mainly offered to those patients considered at "high risk" for open carotid endarterectomy (CEA) based on the available data from large randomized clinical trials. "High risk" has been defined as (1) patients with severe comorbidity (class III/IV congestive heart failure, class III/IV angina, coronary disease involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary disease, severe renal failure) and (2) Technical/challenging anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy). Several recent studies have called medical "high-risk" into question for CAS indication. The purpose of this study is to evaluate the safety and perioperative and long-term effectiveness in patients with significant carotid artery stenosis with "high-risk" criteria (for CEA) treated with carotid stenting and proximal protection device (MOMA®) compared to patients with standard-surgical-risk features.
NCT01343667
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.
NCT00064545
To evaluate common genetic variations, that in combination with exposure to tobacco smoke, may modify the risk of atherosclerosis.