tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction...
Pulmonary EmbolismTo demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter...
Pulmonary EmbolismThe Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Thrombolysis Endovascular Treatment of Pulmonary Embolism
Pulmonary EmbolismAcute Pulmonary EmbolismTo assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
Haemo-autologous Antegrade Repriming (HAR) as Minimum Impact Perfusion Strategy for Cardiopulmonary...
AnemiaCognitive; Disorder7 moreHaemo-autologous Antegrade Repriming (HAR) is a procedure based in the combination of evidence proven measures designed to reduce the haemodilution caused by establishing the cardiopulmonary bypass (CPB) during cardiac surgery. This clinical trial aims to determinate, in one hand, the benefits related to HAR in terms of transfusion, ICU stay, ventilation time, early mortality and complications. In the other hand analyzes the gaseous microemboli (GME) load, comparing the oxygenators venting technology´s efficiency in treatment and control group, and its relation with patient´s neurocognitive status.
Thrombolysis and RIPC in Acute Ischemic Stroke
Acute Ischemic StrokeCerebral Embolism and ThrombosisRemote ischemic postconditioning (RIPC) is suggested to protect the cerebral cell against ischemia in various settings. However, the effect of RIPC in patients with acute ischemic stroke who undergo thrombolysis has yet to be examined. In this single-center, randomized controlled trial, we examined the effect of RIPC on the resolution of nerve function deficient in response to thrombolysis. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis. The primary endpoint was the recovery of nerve function deficient assessed by National Institutes of Health Stroke Scale(NIHSS), Activities of Daily Living(ADL), Modified Rankin Scale(mRS), CT cerebral perfusion imaging (CTP) and CT angiography(CTA). Secondary endpoints included the following: angiogenesis assessed by the level of vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF).
Surgical Pulmonary Embolectomy Versus Catheter-directed Thrombolysis in the Treatment of Pulmonary...
Acute Pulmonary Embolism (PE)Acute pulmonary embolism (PE) is a serious and potentially lethal condition. The clinical spectrum of PE spans from asymptomatic PE to patients with severe hemodynamic compromise. The main determinant of outcome is right ventricular dysfunction caused by the abrupt rise in pulmonary vascular resistance. Patients with hemodynamic compromise are at highest risk of mortality (>15%). Hemodynamic stable patients with imaging and biomarker evidence of right ventricular (RV)- dysfunction are at intermediate-high risk of mortality (3-15%). According to the European Society of Cardiology (ESC) guidelines reperfusion therapy options for patients at high risk and at intermediate-high risk include systemic thrombolysis, catheter-directed therapy or surgical embolectomy. The University Hospital of Bern is the only tertiary care hospital in Switzerland that has established an interdisciplinary pulmonary embolism response team (PERT since 2010) and has gained expertise in both catheter-directed thrombolysis and surgical embolectomy. Since the introduction of PERT, systemic thrombolysis was no longer performed in Bern due to the high risk of intracranial hemorrhage. Favorable clinical outcomes of the patients managed in Bern have been published for both catheter-directed therapy and surgical embolectomy. To date, no study has ever compared catheter-directed thrombolysis versus surgical pulmonary embolectomy in the treatment of high and intermediate-high risk PE patients.
Evaluating the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism...
Pulmonary EmbolismTo determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
Cardiovascular DiseasesThe study is an investigator-initiated trial comparing two different catheters (standard versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood clots in lung arteries with evidence or heart strain). Patients already planned for the procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior to standard CDT, the former being much more expensive and more commonly used. The purpose of the study is to learn about which catheter-directed therapy is more suitable for patients with pulmonary embolism (PE), who are candidates for both standard catheter directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to provide information regarding the cost effectiveness of the two different types of treatment. A total of 80 patients are planned to be recruited. All medication administration, procedures or in-hospital tests will be performed as routine clinical practice. The study will compare short term and long term outcomes: resolution of blood clots on CT scan, right ventricular size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.
Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients
Pulmonary EmbolismThe objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.
Compare Technegas Ventilation-Perfusion SPECT and Xenon Ventilation-Perfusion Planar Imaging for...
Pulmonary EmbolismPhase 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).