Search Clinical Trials
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PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Major Extremity Trauma Research Consortium
Infections
Infected Wound
Nonunion of Fracture
Injury Leg
Amputation
This is a Phase III clinical randomized control trial to investigate differences between
patient with an infected nonunion treated by PO vs. IV antibiotics. The study population
will be 250 patients, 18 years or older, being treated for infected nonunion after
internal fixation of a fracture with... expand
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured. Type: Interventional Start Date: May 2023 |
IKS03 in Patients with Advanced B Cell Non-Hodgkin Lymphomas
Iksuda Therapeutics Ltd.
B-cell Non-Hodgkin Lymphoma
Diffuse Large B Cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
B-cell Lymphoma
This first-in-human study will evaluate the recommended dose for further clinical
development, safety, tolerability, antineoplastic activity, immunogenicity,
pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate,
in patients with advanced B cell non-Hodgkin lymphoma... expand
This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL). Type: Interventional Start Date: Sep 2023 |
iKinnect2.0 for Juvenile Justice Involved Youth at Risk for Suicide
Evidence-Based Practice Institute, Seattle, WA
Child Behavior Disorders
Suicide and Self-harm
This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120
suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a
primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or
Life360 (control app) plus an electronic... expand
This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively. Type: Interventional Start Date: Jun 2023 |
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
University of Alberta
Liver Dysfunction
INTERLIVER is a prospective observational study of the relationship of the molecular
phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical
features and outcomes. A segment of a biopsy performed as standard-of-care for
indications, or by center protocol, will be used... expand
INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study. Type: Observational Start Date: Dec 2017 |
HP Pyruvate MRI in Cancers
University of Maryland, Baltimore
Image
Warburg Effect
Tumors
Many human diseases are characterized by their ability to alter existing metabolic
pathways and interrupt cellular processes. Cancer exploits the Warburg effect and
utilizes greater glucose than normal cells and within this process uses anaerobic
respiration, leading to increased conversion of pyruvate... expand
Many human diseases are characterized by their ability to alter existing metabolic pathways and interrupt cellular processes. Cancer exploits the Warburg effect and utilizes greater glucose than normal cells and within this process uses anaerobic respiration, leading to increased conversion of pyruvate to lactate. This can be exploited by hyperpolarized imaging. Hyperpolarized 13C MRI imaging is an approach that utilizes a stable isotope of Carbon (13C) linked to pyruvate. MRI spectroscopy is used in conjunction with hyperpolarized 13C pyruvate in order to temporally detect pyruvate and its conversion to lactate in-vivo, in order to visualize downstream metabolic (glycolytic) activity secondary to the Warburg effect, which should be useful in detecting and characterizing tumors of various types. Hyperpolarized 13C pyruvate MR imaging has not been tested in most cancers. In this preliminary survey, we will test the hypothesis that hyperpolarized 13C pyruvate MR imaging can be used to image various cancers. Type: Interventional Start Date: Jun 2024 |
ARrest RESpiraTory Failure From PNEUMONIA
Stanford University
Pneumonia
Hypoxemia
Acute Respiratory Failure
COVID-19 Pneumonia
This research study seeks to establish the effectiveness of a combination of an inhaled
corticosteroid and a beta agonist compared to placebo for the prevention of acute
respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. expand
This research study seeks to establish the effectiveness of a combination of an inhaled corticosteroid and a beta agonist compared to placebo for the prevention of acute respiratory failure (ARF) in hospitalized patients with pneumonia and hypoxemia. Type: Interventional Start Date: Jun 2020 |
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients...
NATCO Pharma Ltd.
Carcinoma
Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination
with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy.
A total of approximately 46 male and female patients will be enrolled. This sample size
is based on Simon's 2-stage design... expand
This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%. Type: Interventional Start Date: Sep 2022 |
Protective Arm Balance Responses
University of Maryland, Baltimore
Old Age; Debility
Peripheral Neuropathy
The overall objective of this study is to investigate the effect of attention control
training on reach-grasp stabilizing responses during fall-induced perturbations. The
central hypothesis is that training attention control during reach to grasp balance
perturbations will lead to increased grasp... expand
The overall objective of this study is to investigate the effect of attention control training on reach-grasp stabilizing responses during fall-induced perturbations. The central hypothesis is that training attention control during reach to grasp balance perturbations will lead to increased grasp accuracies and reduced in-task falls. This research will mark the first explore the effects of training attention control on protective arm responses and fall rate during a balance perturbation paradigm and the first feasibility testing of a fully integrated cognitive and physical rehabilitation paradigm, moving beyond correlative designs and parallel treatments. The overall public health significance of the proposed research is that with improved protective arm responses and grasp accuracies, a larger randomized control study may be designed to mitigate falls among community dwelling older adults. Participants will be involved in 6 sessions. Session 1 will include the assessment, questionnaires, and training. Session 2 will include just the training. Session 3 will include the assessment and training. Sessions 4-5 will include just the training. Session 6 will include the assessment, questionnaires, and training. Type: Interventional Start Date: Oct 2023 |
High-Risk Metachronous Oligometastatic Prostate Cancer Trial
University of Maryland, Baltimore
Prostate Cancer
Oligometastatic Disease
The purpose of this research study is to compare the effects, good and/or bad, of using
the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR)
to the metastatic lesions, compared to standard of care and addition of 6-months of
niraparib/abiraterone acetate combination... expand
The purpose of this research study is to compare the effects, good and/or bad, of using the standard of care treatment, hormonal therapy + Stereotactic Ablative Radiation (SABR) to the metastatic lesions, compared to standard of care and addition of 6-months of niraparib/abiraterone acetate combination pills and prednisone for participants with recurrent metastatic prostate cancer. Type: Interventional Start Date: Apr 2024 |
Hyperpolarized 13C-pyruvate Metabolic MRI With Traumatic Brain Injury
University of Maryland, Baltimore
Traumatic Brain Injury
Subarachnoid Hemorrhage
The purpose of this study is to examine the safety and feasibility of using
hyperpolarized metabolic MRI to study early brain metabolism changes in subjects
presenting with head injury and suspected non-penetrating traumatic brain injury (TBI).
This study will also compare HP pyruvate MRI-derived... expand
The purpose of this study is to examine the safety and feasibility of using hyperpolarized metabolic MRI to study early brain metabolism changes in subjects presenting with head injury and suspected non-penetrating traumatic brain injury (TBI). This study will also compare HP pyruvate MRI-derived metrics in TBI patients with healthy subjects as well as Subarachnoid hemorrhage (SAH) patients to better understand if metabolic Magnetic resonance imaging scan (MRI) can improve our ability to diagnose a TBI. The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study. Up to 15 patients (5 with TBI, 5 with SAH, and 5 healthy volunteers) may take part in this study at the University of Maryland, Baltimore (UMB). Type: Interventional Start Date: Oct 2023 |
Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels...
University of Maryland, Baltimore
Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Oropharynx Cancer
Oropharynx Squamous Cell Carcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have
favorable outcomes and how well they do depends on the specific details about the patient
and their cancer. How well they do isn't as related to the kinds of treatment they get.
However, there are significant side... expand
Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment. Type: Interventional Start Date: Mar 2024 |
A Study of RGLS8429 in Patients With Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics Inc.
Autosomal Dominant Polycystic Kidney Disease
ADPKD
Polycystic Kidney, Autosomal Dominant
Primary Objectives
- To assess the safety and tolerability of RGLS8429
- To assess the impact of RGLS8429 on ADPKD biomarkers
Secondary Objectives
- To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV)
- To characterize the pharmacokinetic (PK) properties... expand
Primary Objectives - To assess the safety and tolerability of RGLS8429 - To assess the impact of RGLS8429 on ADPKD biomarkers Secondary Objectives - To assess the impact of RGLS8429 on height-adjusted total kidney volume (htTKV) - To characterize the pharmacokinetic (PK) properties of RGLS8429 - To assess the impact of RGLS8429 on renal function Type: Interventional Start Date: Oct 2022 |
Proper Duration of Suppressive Antibiotic Therapy After Debridement, Antibiotics, and Implant Retention
University of Maryland, Baltimore
Periprosthetic Joint Infection
Antibiotic Suppression
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after
intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty
(TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic
joint infection (PJI). However, little... expand
Multiple studies have demonstrated oral suppressive antibiotic therapy (SAT), after intravenous antibiotics, maximizes reoperation-free survival of total joint arthroplasty (TJA) debridement, antibiotics, and implant retention (DAIR) for acute periprosthetic joint infection (PJI). However, little is known regarding sequelae of SAT after DAIR for PJI. Prior studies have small or heterogeneous patient cohorts, variable antibiotic regimens, arrive at disparate conclusions, and do not establish antibiotic resistance risk. The investigators propose a prospective randomized controlled multicenter study to expand on findings in a retrospective, multi-center pilot study. Study aims are to evaluate SAT after DAIR of acutely infected primary TJA regarding: 1) adverse drug reactions/intolerance; 2) reoperation for infection; and 3) antibiotic resistance. Type: Interventional Start Date: Apr 2024 |
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
Microvention-Terumo, Inc.
Intracranial Aneurysm
The objective of this study is to generate contemporaneous clinical data to facilitate a
reasonable comparison of the performance of the FRED™ X™ device with the performance of
the FRED™ device. The data generated from this study will be compared to the safety and
effectiveness of the FRED™ device... expand
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the FRED™ pivotal study. Type: Interventional Start Date: Sep 2022 |
Strengthening Family Coping Resources Open Trials
University of Maryland, Baltimore
Intervention Effectiveness
Practice-based Evidence
Posttraumatic Stress Disorder
Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of
the National Institute on Drug Abuse's intervention development model by testing a new
family, skills-based intervention involving pre-post evaluation of families participating
in multi-family groups. The purpose... expand
Strengthening Families Coping Resources (SFCR) Open Trials completes the second stage of the National Institute on Drug Abuse's intervention development model by testing a new family, skills-based intervention involving pre-post evaluation of families participating in multi-family groups. The purpose of this study is to gather practice-based evidence on the effectiveness of the manualized treatment, on the dynamics involved in the group format, and on implementation fidelity and feasibility. Analyses will involve initial exploration of the following hypotheses: 1) Families will show a significant increase in the constructive use of family coping skills and in general family functioning. 2) The target child will show a reduction in trauma-related symptoms and behavior problems. 3) Parents will show significant reductions in traumatic stress and other symptoms of distress. 4) Families will engage and participate in the treatment. 5) Providers will implement SFCR with fidelity. Other outcomes of interest are the process measures that will be collected to monitor participation in the groups, cultural sensitivity and acceptability, clinician competence, and intervention integrity. Type: Observational Start Date: Feb 2006 |
Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness
University of Maryland, Baltimore
Prostatic Neoplasm
Survivorship
Frailty
Aging
Frailty is one of the main reasons older adults lose independence. Frailty describes a
reduced ability to withstand stress on the physiological scale, or a reduced
physiological reserve. The theory is that entrainment of circadian rhythm via
time-restricted eating will improve the body's ability to... expand
Frailty is one of the main reasons older adults lose independence. Frailty describes a reduced ability to withstand stress on the physiological scale, or a reduced physiological reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will improve the body's ability to predict energy supply and demand, and therefore enable the body to allocate more resources to anabolic processes and promote resilience to cancer treatment, thereby preventing the progression of frailty. A total of 30 individuals over 55 years old undergoing ADT therapy for prostate cancer will be recruited. Participants will be randomized 1:1 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention. At baseline and post-intervention, Fried's Frailty Index will be used to assess frailty, and a novel set of five physiological responsiveness measures will be used to assess physiological responsiveness-1) lying-to-standing blood pressure, 2) heart rate variability, 3) oral glucose tolerance test, 4) 24-hour circadian cortisol rhythm, and 5) usual vs. fast gait speed. These data will allow assessment of 1) the feasibility of TRE among patients with prostate cancer during ADT treatment with the ultimate goal of optimizing an intervention to prevent the progression of frailty, and 2) the effects of TRE vs. control on frailty and physiological responsiveness. Type: Interventional Start Date: Jan 2024 |
Sensory-Motor Rehabilitation Post Stroke
University of Maryland, Baltimore
Acute Stroke
Early after stroke, patients often have significant motor impairment and sensory deficit.
Evidence has demonstrated heightened plasticity and significant recovery in the acute
phase (first months) post stroke but there has been a lack of effective and practical
protocols and devices for early intensive... expand
Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors. Type: Interventional Start Date: Apr 2019 |
Screening for Atrial Fibrillation in Elderly Women Older Than 70 Years
University of Maryland, Baltimore
Atrial Fibrillation New Onset
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating
the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the
population. Studies have shown that women with Afib are more likely to be symptomatic,
have increased mortality from stroke resulting... expand
Screening for Atrial Fibrillation in Elderly Women (SAFE-W) is a pilot study evaluating the prevalence of atrial fibrillation (Afib) in a rapidly aging segment of the population. Studies have shown that women with Afib are more likely to be symptomatic, have increased mortality from stroke resulting from Afib, and are less likely to receive treatment for Afib. University of Maryland Department of Neurology and Vascular Neurology are recruiting women older than 70 years of age to participate in the study. Type: Interventional Start Date: Jul 2023 |
Transnasal Induction of Normothermia for Neurogenic Fever
CoolTech LLC
Stroke, Ischemic
Stroke Hemorrhagic
Seizures
Metabolic Encephalopathy
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal
Thermal Regulating Device in reducing temperature in a population of febrile subjects who
meet the inclusion/exclusion criteria. expand
The objective of this study is to evaluate the efficacy of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria. Type: Interventional Start Date: Nov 2023 |
Sickle Cell Children's Exercise Study (SuCCESs)
University of Maryland, Baltimore
Sickle Cell Disease
The Sickle Cell Children's Exercise Study (SuCCESs) will explore the feasibility and
effects of a moderate intensity strengthening, balance, speed, and agility intervention
program in children with sickle cell disease. expand
The Sickle Cell Children's Exercise Study (SuCCESs) will explore the feasibility and effects of a moderate intensity strengthening, balance, speed, and agility intervention program in children with sickle cell disease. Type: Interventional Start Date: Nov 2023 |
Efficacy of a Transcranial Vibrating System for Minimizing Dizziness During Caloric Testing
Otolith Labs
Vestibular Function Tests
Dizziness
Testing for vestibular dysfunction often induces dizziness and nausea, to the point that
testing cannot be completed. The investigators will use a "transcranial vibration system"
that has shown promise in improving comfort during testing for vestibular disorders.
The investigators hypothesize that... expand
Testing for vestibular dysfunction often induces dizziness and nausea, to the point that testing cannot be completed. The investigators will use a "transcranial vibration system" that has shown promise in improving comfort during testing for vestibular disorders. The investigators hypothesize that with this "transcranial vibration system", the dizziness and nausea associated with caloric testing will be significantly reduced, while the clinical measures derived from the test will not be statistically significantly altered. Type: Interventional Start Date: Oct 2018 |
DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)
Cellphire Therapeutics, Inc.
Cardiac Surgery
A randomized, parallel group, active comparator-controlled trial to evaluate the
non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in
controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. expand
A randomized, parallel group, active comparator-controlled trial to evaluate the non-inferiority or superiority of Cryopreserved Platelets with Liquid Stored Platelets in controlling blood loss in patients undergoing Cardiopulmonary Bypass Surgery. Type: Interventional Start Date: Sep 2021 |
TMS Related Biomarker Assessments
University of Maryland, Baltimore
Schizophrenia Schizoaffective
Schizophrenia
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham
repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related
biomarkers will be assessed before and after the rTMS administration. expand
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration. Type: Interventional Start Date: Jan 2023 |
Ankle Robotics After Stroke
NextStep Robotics Inc.
Foot Drop
Stroke
Hemiparesis
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9
weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT)
alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak
swing ankle angle, number of heel-first... expand
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs). Type: Interventional Start Date: Aug 2020 |
A Clinical Evaluation of the MicroSTent® PeripherAl Vascular SteNt in Subjects With Arterial Disease...
Micro Medical Solution, Inc.
Peripheral Arterial Disease
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA
plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the
safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System,
hereafter referred to as the MicroStent®... expand
Randomized multicenter clinical trial consisting of two arms; one arm treated with PTA plus the MicroStent® System and one arm treated with PTA alone. Purpose to evaluate the safety and effectiveness of using the MicroStent® Peripheral Vascular Stent System, hereafter referred to as the MicroStent® System, for the treatment of infrapopliteal lesions in subjects with peripheral arterial disease. Type: Interventional Start Date: Jun 2019 |
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