279 Clinical Trials for Various Conditions
Evaluation of the Safety and Efficacy of the Symphony Thrombectomy System in the Treatment of Pulmonary Embolism
Evaluate the safety and efficacy of the Aventus Thrombectomy System for aspiration thrombectomy in subjects with acute pulmonary embolism.
The Researchers are studying whether a vascular boot warming program plus standard of care anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT) ±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS). Additionally, to learn whether a more detailed imaging of the affected lower extremities will provide a more accurate and reliable method to guide treatment for this condition.
This is an observational study designed to investigate the role of fat emboli in patients who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of this study is to obtain samples of bone marrow and blood during tibial or femoral fracture procedures to understand the inflammatory response.
The purpose of this study is to use transesophageal echocardiography (TEE) to determine the incidence, severity, and clinical significance of gas bubbles during argon plasma coagulation (APC).
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as non-central nervous system systemic embolism) in patients with non-valvular atrial fibrillation (a heart rhythm disorder).
Objectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.
The purpose of the study is to see if there is a difference in the amount of fat droplets reaching the heart during surgery between the standard reamer currently used and a new reamer system which is expected to reduce the fat going into the blood, via an intraoperative echocardiography done through the food pipe.
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.
Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas. The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation. The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.
A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE). Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.
To establish a clinical registry of suspected cases of AFE. The existing registry will be migrated to a new platform,
The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).
Researchers are looking for a better way to treat people with atrial fibrillation (AF) and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel). Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them. Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding. The study treatment asundexian is a new type of anticoagulant currently under development to provide further treatment options. Asundexian aims to further improve the standard of care with regard to the risk of bleeding. The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke. To see how well the study treatment asundexian works researchers compare: * how long asundexian works well and * how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening: * stroke and/or * systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study. To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health. The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months. Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases. During the study, the study team will: * take blood samples * do physical examinations * examine heart health using an electrocardiogram (ECG) * check vital signs such as blood pressure and heart rate * do pregnancy tests * ask the participants questions about their quality of life * ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.
The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.
Potential outcomes after PE occur on a spectrum: complete recovery, exercise intolerance from deconditioning/anxiety, dyspnea from concomitant cardiopulmonary conditions, dyspnea from residual pulmonary vascular occlusion, chronic thromboembolic disease and chronic thromboembolic pulmonary hypertension. Although a battery of advanced diagnostic tests could distinguish each of those conditions, the yield of individual tests among all post- PE patients is low enough that routine testing of all PE patients is not typically performed. Although the various possible post-PE outcomes have enormous implications for patient care, they are rarely distinguished clinically. Perhaps for this reason, chronic conditions after PE are rarely (if ever) used as endpoints in randomized clinical trials of acute PE treatment. The proposed project will validate a clinical decision tree to distinguish among the various discrete outcomes cost-effectively through a hierarchical series of tests with the acronym SEARCH (for symptom screen, exercise function, arterial perfusion, resting heart function, confirmatory imaging and hemodynamics). Each step of the algorithm sorts a subset of patients into a diagnostic category unequivocally in a cost-effective manner. The categories are mutually exclusive and collectively exhaustive, so that each case falls into one, and only one, category. Each individual test used in the algorithm has been clinically validated in pulmonary embolism patients, including the cardiopulmonary exercise test (CPET) technique that the investigators developed and validated. However, the decision tree approach to deploying the tests has not yet been validated. Aim 1 will determine whether the SEARCH algorithm will yield concordant post-PE diagnoses when multiple reviewers independently evaluate multiple cases (reliability). Aim 2 will determine whether the post-PE diagnoses are stable, according to the SEARCH algorithm, between the first evaluation and the subsequent one six months later (validity).
To evaluate the safety and effectiveness of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 PE in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
Clinical presentation of acute pulmonary embolism (PE) is complex and varied and not uncommonly involves respiratory failure with dyspnea or hypoxia. Patients with persisting signs of respiratory failure despite anticoagulation, may benefit from catheter directed thrombectomy. Additionally, patient who receive thrombectomy are likely to have a lower residual thrombus burden measurable by ventilation-perfusion (V/Q) scan, and thereby less likely to develop chronic sequela, including chronic thromboembolic pulmonary hypertension (CTEPH) and post PE syndrome.
The objective of the study is to evaluate the safety and efficacy of the Adient absorbable filter for the prevention of pulmonary embolism (PE: blood clot in the lungs). PE claims the lives of over 100,000 Americans each year, more than breast cancer, traffic fatalities and HIV combined. Pharmaceutical anticoagulation (blood thinners) that reduce blood clot formation represent the standard of care for treating patients at risk for PE. However, for people who are temporarily unable to use anticoagulants, such as those who have suffered major trauma or those who are scheduled for surgical procedures, inferior vena cava (IVC) filters are used to help protect against PE. These blood filters prevent large blood clots that originate in the deep veins of the legs (deep vein thrombosis (DVT)) from reaching your lungs causing a potentially life-threatening PE. Conventional metal IVC filters have been proven effective at reducing the incidence of PE, however, most require retrieval. If not retrieved within a timely manner (months), they can perforate the IVC, impale nearby organs with their barbed struts, and cause blood clots. In contrast, the Adient absorbable filter traps blood clots similar to conventional metal IVC filters, but following the 8 week protection period, the filter itself breaks down into carbon dioxide and water. Hence no filter retrieval is required and complications are less likely due to the shortened indwell time. Once blood clots are trapped in the absorbable filter, the body's thrombolytic enzymes dissolve the clots within weeks while the filter itself resorbs in 6 to 8 months. The absorbable filter is braided from absorbable suture that has been proven safe over 4 decades. The question being addressed with the randomized controlled trial portion is whether the placement of the absorbable filter in addition to current best practice PE prevention (sequential compression machines, compression stockings, and anticoagulants when indicated) significantly reduces the incidence of clinically significant PE in high risk subjects. The absorbable filter will be indicated for the temporary prevention of PE in patients with transient high risk for venous thromboembolism (DVT and/or PE) with or without venous thromboembolic disease and as an enhancement to pharmaceutical anticoagulation and mechanical prophylaxis.
This study is an observational, prospective study examining the role point-of-care echocardiography of predicting short term adverse outcomes in emergency department patients with acute pulmonary embolism. The primary objective is to assess the diagnostic performance of ultrasound-guided measures of right ventricular dilation (RVD) and strain in predicting clinical outcomes in acute PE. The secondary objective is to investigate the utility of combining ultrasound-guided measures of RVD and the pulmonary embolism severity index (PESI) score in predicting adverse outcomes in acute PE.
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.
* There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. * These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. * When DIC is associated with COVID-19, it predicts a very poor prognosis. * This study will evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. * Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. * The study will generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients