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International BPA Registry
Rochester, MN
The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).
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A Study to Investigate Outcomes and Management Effectiveness of Cardiogenic Shock II Patients
Rochester, MN
The purpose of this study is to develop a registry of patients with clinical cardiogenic shock (CS) in order to allow better definition of several key issues regarding cardiogenic shock.
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A Study of Pulmonary Artery Angioplasty on Exercise Capacity and Symptoms in Children and Adults with Unilateral Proximal Pulmonary Artery Stenosis
Rochester, MN
The purpose of this study is to find out the effect of opening up a narrowed blood vessel supplying the lungs (pulmonary artery) on the exercise capacity of these subjects.
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A Study of Mesenchymal Stem Cell (MSC) Adherence and Vessel Wall Penetration Following Intra-arterial Delivery Subsequent to Controlled Balloon Angioplasty
Jacksonville, FL
The purpose of this study is to determine the amount of MSCs that adhere to predetermined areas of arterial wall following balloon angioplasty vs no intervention, and to characterize the effect of intra-arterial injection of MSCs on predetermined areas of arterial wall via transcriptome analysis.
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A Study with to Assess the Effectiveness and Safety of Selexipag as Standard-of-Care Add-on in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment CTEPH
Rochester, MN
The purpose of this study is to assess the effectiveness and safety of Selexipag in subjects with inoperable or persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
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Genetic Causes of Stent Thrombosis
Rochester, MN
The purpose of this study is to identify novel genetic variants associated with stent thrombosis.
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Routine Hemodynamic Monitoring following Percutaneous Coronary Interventions
Rochester, MN
We will identify the prevalence of hemodynamic abnormalities following percutaneous coronary interventions (PCI). Second, among patients with hemodynamic problems, we will be able to identify problems for which action needs to be taken. Third, pursuant to the results of our study, we can identify the clinical utility of such monitoring and will be able to target such monitoring to at-risk patients and will likely obviate the need for routine monitoring, propose cost-effectiveness measures, and propose same day discharge on low-risk patients.
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Study to Assess the Effects of Intravenous Bendavia in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery (PTRA)
Rochester, MN
The primary objective of this trial is to assess the effects of Bendavia on renal blood flow and renal function in atherosclerotic renal artery stenosis (ARAS), compared with placebo in patients with ARAS who receive one dose of study drug infused 30 minutes before and 3 hours after percutaneous transluminal angioplasty of the renal artery (PTRA).
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A Study Comparing Carotid Revascularization Endarterectomy Versus Stenting
Jacksonville, FL
The purpose of this study is to compare the relatively new procedure of stent-assisted carotid angioplasty to the traditional and accepted surgical approach of carotid endarterectomy for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).
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Long-Term Observational Extension of Participants in CREST-2Trial
Scottsdale/Phoenix, AZ
The purpose of this Long-Term Observational Extension of Participants in the CREST-2 Randomized Clinical Trial study is to assess post-procedural efficiency of carotid endarterectomy and carotid stenting.
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Cardiovascular Disease Specimen Repository
Rochester, MN
The purpose of the study is collect specimens for future studies to identify markers circulating in the blood that are associated with the development of further complications of heart disease.
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial
Jacksonville, FL; Rochester, MN
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.
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Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial - Hemodynamics (CREST-H)
Jacksonville, FL; Rochester, MN
We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral ...
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A Study to Evaluate Virtual Remote Control Robotic Percutaneous Coronary Intervention
Rochester, MN
The purpose of this study is to evaluate whether or not robotic percutaneous coronary interventin (PCI) can be performed safely and effectively with the primary operator located in an adjacent control room using a remote control telecommunications system.
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Virtual World-based Cardiac Rehabilitation Program to Encourage Healthy Lifestyle Choices Among Cardiac Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The aim of this project is to assess the feasibility and utility of a virtual world-based cardiac rehabilitation (CR) program as an extension of a face-to-face conventional CR program (Destination Rehab).