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Exercise Plus Duloxetine for Knee Osteoarthritis
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University of Maryland, Baltimore
Knee Osteoarthritis
Depression
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of
symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will
receive the receive the treatment protocol, which will first be evaluated in terms of
feasibility... expand
This study evaluates the addition of duloxetine to aerobic exercise in the treatment of symptomatic knee osteoarthritis and depressive symptoms in adults. All participants will receive the receive the treatment protocol, which will first be evaluated in terms of feasibility and then pilot tested. Type: Interventional Start Date: Oct 2021 |
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus...
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National Institute of Allergy and Infectious Diseases (NIAID)
Respiratory Syncytial Virus (RSV)
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of
the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV
ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24
months of age.... expand
The purpose of this study is to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age. Type: Interventional Start Date: May 2019 |
Hip Muscle Power, Lateral Balance Function, and Falls in Aging
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University of Maryland, Baltimore
Accidental Falls
Falls and their consequences are among the major problems in the medical care of older
individuals. The long-term goal of this research is to develop a mechanistically based
therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral
balance function... expand
Falls and their consequences are among the major problems in the medical care of older individuals. The long-term goal of this research is to develop a mechanistically based therapeutic intervention to enhance muscle power, weight-shifting capability, and lateral balance function through protective stepping to prevent falls. When human balance is challenged, protective stepping is a vital strategy for preventing a fall during activities of daily life. Many older people at risk for falls have particular difficulties with successfully stepping sideways as a protective response to loss of balance in the lateral direction. Age-related declines in lateral balance function result from neuromuscular and biomechanical limitations in hip abductor-adductor muscle power generation. This study will test whether these impairments can be improved with high-velocity hip muscle resistance power training that will be more effective than conventional resistance strength training. Type: Interventional Start Date: Sep 2019 |
MR Guided Focused Ultrasound (FUS) for the Treatment of Trigeminal Neuralgia
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University of Maryland, Baltimore
Trigeminal Neuralgia
The purpose of this study is to assess the safety and effectiveness of MRI-guided focused
ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type
of pain involving the face that can be disabling to those it affects.
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The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating Trigeminal Neuralgia. Trigeminal Neuralgia (pain) is a type of pain involving the face that can be disabling to those it affects. Type: Interventional Start Date: Feb 2021 |
Robot Aided Rehabilitation - Multi-joint Evaluations
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University of Maryland, Baltimore
Stroke
Sensory and motor impairments following stroke can lead to substantial disability involving
the arm and hand. The investigator hypothesized that excessive local and cross-coupled
stiffness, diminished individuation and proprioceptive acuity will be present among multiple
degree... expand
Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot. Type: Observational Start Date: May 2018 |
Blood-brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Standard of Care Treatment...
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InSightec
Brain Tumor
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain
barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain
metastases in patients who are undergoing planned pembrolizumab monotherapy.
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The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned pembrolizumab monotherapy. Type: Interventional Start Date: Aug 2022 |
Hyperbaric Oxygen Brain Injury Treatment Trial
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Hennepin Healthcare Research Institute
Traumatic Brain Injury
The purpose of this innovative adaptive phase II trial design is to determine the optimal
combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate
improvement in the outcome of severe TBI patients in a subsequent phase III trial.
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The purpose of this innovative adaptive phase II trial design is to determine the optimal combination of hyperbaric oxygen treatment parameters that is most likely to demonstrate improvement in the outcome of severe TBI patients in a subsequent phase III trial. Type: Interventional Start Date: Jun 2018 |
Evaluation and Follow-up of People With Tick-borne Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
Lyme Disease
Tick-Borne Disease
Background:
Lyme disease is the most common tick-borne disease in the United States, but other diseases
transmitted by ticks have also been on the rise in recent years. Early symptoms of a
tickborne disease include fever, headache, fatigue and possible rash. Researchers... expand
Background: Lyme disease is the most common tick-borne disease in the United States, but other diseases transmitted by ticks have also been on the rise in recent years. Early symptoms of a tickborne disease include fever, headache, fatigue and possible rash. Researchers want to collect information and samples from people with Lyme disease and other tick-borne illnesses to better understand and diagnose these diseases. Objective: To evaluate and follow people with tick-borne diseases to help researchers learn more about these infections. Eligibility: People ages 18 and older who have or are suspected of having a tick-borne infection. Design: Participants will have an initial visit, and visits about 1, 6, and 12 months later. The visits can include a physical exam, blood tests, collection of blood, urine and saliva samples for research, and filling out health-related questionnaires. Participants who have the rash of Lyme disease may be invited to have up to 3 skin punch biopsies of the rash for research. Type: Observational Start Date: Dec 2023 |
Study of VXCO-100, a SARS-CoV Candidate Vaccine in Healthy Adults in the United States
Vaccine Company, Inc.
SARS-CoV
SARS-CoV-2
The purpose of this study is to evaluate the safety and immunogenicity of ascending dose
levels of VXCO-100 in healthy adults.
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The purpose of this study is to evaluate the safety and immunogenicity of ascending dose levels of VXCO-100 in healthy adults. Type: Interventional Start Date: May 2023 |
Safety, Tolerability and Efficacy of AntiBKV as Treatment of BKV Infection in Kidney Transplant Recipients
Memo Therapeutics AG
BK Viremia
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in
reducing BK viremia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients
(KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV... expand
The purpose of this study is to evaluate the safety, tolerability, and efficacy of AntiBKV in reducing BK viremia and progression to biopsy-confirmed BKVAN in Kidney Transplant Recipients (KTRs). The study includes two parts. The phase II part will evaluate the safety of AntiBKV in KTRs and establish proof of concept. The phase III part will assess the efficacy of AntiBKV in KTRs. For both the phase II and phase III parts, participants will be randomized to receive either four doses of AntiBKV or four doses of placebo (every 4 weeks). Both the phase II and phase III parts will follow identical study assessments and schedules for participants. Based on an interim analysis after phase II total sample size for the trial will be defined. Eligible participants will receive an intravenous infusion of the investigational medicinal product (IMP) that will be administered four times at a 4-week interval. Seven days following the first IMP administration, participants will be re-evaluated for BK viremia and, if appropriate, changes of immunosuppressive treatment will be started. After administration of the final dose, participants will return as out participants for periodic safety, BK viremia, and PK follow-up assessments until the end of the trial visits, 26 weeks post last IMP application. Regular kidney biopsies will be performed at baseline (prior to infusion) and on Day 141 (8 weeks after full dosing). An additional biopsy will be taken on Day 267 (optional) and as clinically indicated. Type: Interventional Start Date: Apr 2023 |
A Study Evaluating the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen (BCMA)-Exposed...
Hoffmann-La Roche
Multiple Myeloma
This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in
participants with refractory multiple myeloma (R/R MM) via intravenous (IV) infusion.
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This study will evaluate the efficacy, safety, and pharmacokinetics of cevostamab in participants with refractory multiple myeloma (R/R MM) via intravenous (IV) infusion. Type: Interventional Start Date: Oct 2022 |
Bringing Health Home
University of Maryland, Baltimore
Mental Disorders, Severe
Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse
health and social outcomes compared to the general population due to a high prevalence of
chronic physical health disorders such as cardiovascular disease, hypertension, and Type II
Diabetes,... expand
Individuals suffering from Serious Mental Illnesses (SMI) are at risk for serious adverse health and social outcomes compared to the general population due to a high prevalence of chronic physical health disorders such as cardiovascular disease, hypertension, and Type II Diabetes, along with consequences of mental distress such as suicide, substance abuse, and acute stress.While pharmacological treatments exist for these conditions, they have limited effectiveness in SMI populations because: (1) up to 60% of individuals with SMI do not take their psychiatric or somatic medications as prescribed, (2) individuals with SMI have poorer clinical outcomes and experience high rates of hospitalizations, and (3) individuals with SMI experience worse care. Challenges in the management of these complex chronic health and mental health conditions have led to the development of intensive community-based service delivery programs. However, as currently structured these intensive in-person interventions have only had limited impact optimizing service delivery, and consequently on adherence to treatment and health outcomes. While in-person clinical contact in select situations is important, telehealth may serve as an effective and nimble intervention to help meet the high need for clinical intervention for SMI populations and particularly those with geographically limited-service access. Although research exists regarding the efficacy of telehealth with SMI populations, most of the existing interventions with this population have been designed for institutional settings, not community settings, because of barriers to adoption of telehealth such as limited access to digital technology, technical support difficulties and cost of necessary technology. The COVID-19 pandemic has underscored the need for developing effective telemedicine and telemonitoring technologies to serve the unique needs of this vulnerable population in community settings. This project builds on a successful Phase I SBIR project and ongoing Phase II clinical trial of the Medherent medication management platform. This study will test an expanded set of telehealth care-coordination services that can be used to address the broad health needs of individuals diagnosed with SMI living in community settings and supported by community mental health agencies. The study team will recruit 300 individuals, including 200 individuals currently using the device and 100 new users of the device. The study will test the existing Medherent platform and a set of extended services. Our key outcomes include acute service use, receipt of preventive and other health screenings, health outcomes and costs of services. The study will use a Stepped Wedge Design approach with a matched comparison group to identify potential benefits of the intervention. Type: Interventional Start Date: May 2022 |
Pilot Testing a Digital Intervention to Improve Smoking Cessation in Persons With Serious Mental Illness
University of Maryland, Baltimore
Tobacco Cessation
All patients with serious mental illness are abstinent while in the hospital for a
psychiatric admission yet almost all return to smoking after discharge. The investigators
propose to adapt a digital intervention both to the needs of SMI smokers and to being
introduced in... expand
All patients with serious mental illness are abstinent while in the hospital for a psychiatric admission yet almost all return to smoking after discharge. The investigators propose to adapt a digital intervention both to the needs of SMI smokers and to being introduced in the inpatient psychiatric setting through a collaboration between experts in SMI and the Truth Initiative, a pre-eminent tobacco control organization. The investigators believe this will bridge the inpatient to outpatient gap in cessation services and will help people remain abstinent following hospital discharge. Type: Interventional Start Date: Jan 2021 |
RejuvenAir® System Trial for COPD With Chronic Bronchitis
CSA Medical, Inc.
Chronic Bronchitis
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air
within the lungs and is a major public health problem that is projected to rank fifth
worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB)
is... expand
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality. Type: Interventional Start Date: Jul 2020 |
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
Amgen
Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in
children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study
hypothesis is that in pediatric subjects with chronic migraine, the combined erenumab dose
group... expand
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine. The study hypothesis is that in pediatric subjects with chronic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP). Type: Interventional Start Date: Sep 2019 |
Gastroschisis Outcomes of Delivery (GOOD) Study
Medical College of Wisconsin
Gastroschisis
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7
weeks in stable patients with gastroschisis is superior to observation and expectant
management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will
complete... expand
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Type: Interventional Start Date: Feb 2018 |
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC
Candel Therapeutics, Inc.
Non Small Cell Lung Cancer
The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug
for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint
inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is... expand
The purpose of this clinical trial is to evaluate the effects of adding CAN-2409 + prodrug for stage III/IV NSCLC patients who are on standard of care first line immune checkpoint inhibitor (ICI) treatment with evidence that the clinical response is inadequate. CAN-2409 is a viral immunotherapy approach that induces tumor-infiltrating T-cells and a consequent PD-L1 up-regulation. A combination of CAN-2409 added to standard of care (SOC) checkpoint inhibitors may lead to improved long-term outcomes for patients with NSCLC who have suboptimal response to ICI therapy. Type: Interventional Start Date: Oct 2020 |
Sleep for Stroke Management and Recovery Trial
University of Michigan
Ischemic Stroke
Sleep Apnea
Sleep Apnea, Obstructive
TIA
Stroke
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA)
with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA
(1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after... expand
The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke. Type: Interventional Start Date: May 2019 |
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.
University of Miami
Hypoplastic Left Heart Syndrome
The objectives of this pilot study are to evaluate the feasibility and safety of
intramyocardial injection of autologous c-kit+ cells during the Stage II BDCPA operation and
to observe effects on clinical outcome including right ventricular myocardial function,
severity of... expand
The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II BDCPA operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality. Type: Interventional Start Date: Oct 2019 |
The CREST-2 Registry
University of Maryland, Baltimore
Carotid Artery Diseases
The objective of C2R is to promote the rapid initiation and completion of enrollment in the
CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe
symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid... expand
The objective of C2R is to promote the rapid initiation and completion of enrollment in the CREST-2 randomized clinical trial (clinicaltrials.gov ID NCT02089217). Patients with severe symptomatic and asymptomatic carotid artery occlusive disease will be treated with carotid artery stenting (CAS) performed by experienced and skilled interventionists. Interventionists' eligibility will be determined by a multi-specialty Interventional Management Committee (IMC). Patient eligibility will include patients with standard or high-risk, symptomatic or asymptomatic carotid artery disease. Patients will be followed for the occurrence of post-procedural complications. The primary safety and quality endpoint will be the occurrence of any stroke or death within the 30-day period following the stenting procedure. The safety and quality results from C2R will guide selection of interventionists for participation in the CREST-2 randomized clinical trial. Enrollment into C2R will begin in 2015 and continue until publication of the primary results of the randomized trial. Type: Observational [Patient Registry] Start Date: Feb 2015 |
Peer Activate: Trial of Peer-Delivered Behavioral Activation for Methadone Adherence
University of Maryland, College Park
Substance-Related Disorders
Opioid Medication Assisted Treatment
Opioid Use Disorder
Opioid Use
Opioid Addiction
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led,
brief, behavioral intervention to improve adherence to medication for opioid use disorder
(MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in
Baltimore,... expand
The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) among low-income, minority individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this Type 1 hybrid effectiveness-implementation randomized controlled trial (RCT), we will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over six months. Type: Interventional Start Date: Apr 2022 |
An Engineering-Based Balance Assessment and Training Platform
VA Office of Research and Development
Balance Deficits
Stroke
This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train
dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the
investigators previously developed and validated. In the BRT subjects stand and point to a... expand
This is a proposal to develop a Balanced Reach Training Protocol (BRTP) to evaluate and train dynamic standing balance. The BRTP is based upon the Balanced Reach Test (BRT) that the investigators previously developed and validated. In the BRT subjects stand and point to a target disk moving unpredictably across a large projection screen in front of them without stepping. Body movements undertaken to track the disk are integral to many daily activities and represent an important class of "expected" balance disturbances that can precipitate falls. The BRTP employs engineering and psychophysical methods, and exploits advances in real time computing in a novel and innovative way to more effectively evaluate and train balance function. The BRTP presents a challenging reaching/tracking task that subjects perform at their limit of balance. The BRTP is an objective, quantitative test that can evaluate balance function without floor or ceiling effects, and train balance across the spectrum of aging, disease, and injury. Type: Interventional Start Date: Nov 2021 |
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve...
Abbott Medical Devices
Mitral Regurgitation
Mitral Insufficiency
Mitral Valve Insufficiency
Cardiovascular Diseases
Valve Disease, Heart
Prospective, controlled, multicenter clinical investigation with four trial cohorts:
Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral
Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort
will be... expand
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification. This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort. Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years. Type: Interventional Start Date: Jun 2018 |
Systemic Hypothermia in Acute Cervical Spinal Cord Injury
University of Miami
Spinal Cord Injury, Acute
This study is a prospective multi-center trial designed to determine the safety profile and
efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8)
Spinal Cord Injury (SCI).
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This study is a prospective multi-center trial designed to determine the safety profile and efficacy of modest (33ºC) intravascular hypothermia following acute cervical (C1 to C8) Spinal Cord Injury (SCI). Type: Interventional Start Date: Aug 2017 |
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Thomas G. Brott, M.D.
Carotid Stenosis
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 patients with asymptomatic high-grade carotid... expand
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 patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed. Type: Interventional Start Date: Dec 2014 |