View clinical trials related to Pulmonary Embolism.
Filter by:The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.
The primary objective is to demonstrate the clinical benefits of diclofenac (added to standard anticoagulant therapy) over placebo in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction. The secondary objective is to assess the safety after administration of diclofenac in normotensive patients with acute symptomatic pulmonary embolism and right ventricular dysfunction.
Phase 3 within-subject trial of Technegas V/Q SPECT and Tc-99m macro-aggregated albumin (MAA) imaging compared to Xenon-133 V/Q planar and Tc-99m macroaggregate of albumin (MAA) imaging for the diagnosis of Pulmonary Embolism (PE).
Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment. Aim The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism. Hypothesis The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants. Design This is a multicenter, multinational, randomized, open label trial. Patients Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding. Sample size A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75 events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of 1000 patients will need to be included. Organisation Outcomes will be adjudicated by a central adjudication committee. A steering committee will be formed, preferably consisting of one member of every participating center. An electronic case report form will be used for data collection. Also, an electronic trial master file will be used.
- The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism - Thoracic CT angiography (CTA) will serve as reference standard - Result of MRI will not interfere with patients' management - Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease
There is a clear link between obstructive sleep apnea (OSA) and cardiovascular disease. However, there has been no clear link between OSA and venous thromboembolism (VTE). The objective of this study is to evaluate such a link.
Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.
The purpose of this study is to determine if tenecteplase plus enoxaparin is safe and effective in the treatment of patients with severe submassive pulmonary embolism.
Hypothesis: Increases in CRP, trop T, and BNP values will correlate significantly with right heart failure on echocardiogram and with mortality, ICU stay, hospital stay, and escalations in care. 1. Evaluate whether CRP, trop T, and BNP correlate significantly with right heart failure on echocardiogram. 2. Evaluate whether CRP, trop T, BNP, and echocardiogram correlate significantly with clinical outcomes: mortality, ICU stay, hospital stay, and escalations in care. 3. Compare each test's correlation with clinical outcomes to the others, to determine which test provides the best risk ratio. 4. Compare each trop T value's correlation with echo findings and clinical outcomes to determine the optimal time to draw trop T levels on a patient presenting with acute PE. 5. These tests will not be used in an attempt to establish a diagnosis of PE.
Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F. Treatment: Aspirex 11F assisted thrombectomy _________ The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device. _________ Primary Endpoints: 1. Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP). 2. The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures. Secondary Endpoints: 1. Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index. 2. There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels. 3. In-hospital mortality will not exceed 20%. Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device. Sample Size: Maximum of 50 patients Inclusion Criteria: - Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis. Exclusion Criteria: - Systemic embolism in the presence of an arterial septal defect or patent foramen ovale. - Free floating right heart thrombi, left heart thrombi. - Life expectancy, due to underlying disease, less than one month.