Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation...
Chronic Kidney DiseasesAtrial Fibrillation8 moreObjective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events. The secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation. Trial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months. Trial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)* <20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is <15 ml/min/1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation. The exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein. Interventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation. Outcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)
Proton Beam Radiotherapy Followed by Tecentriq and Avastin for Primary Liver Cancer With Vp2-4 Portal...
Hepatocellular CarcinomaPortal Vein ThrombosisThis study is investigator initiated, single-institution, prospective, phase 2 open-label study to determine the efficacy and safety of combination therapy of atezolizumab/bevacizumab and proton beam therapy to portal vein tumor thrombosis with or without main primary tumor in patients with stage 3 or higher hepatocellular carcinoma (HCC) with Vp2-4 portal vein invasion who had not undergone systemic therapy for HCC. The primary endpoint of this study is progression-free survival and secondary endpoints are overall survival (OS), time to progression (TTP), objective response rate, disease control rate (DCR), and time to local disease progression (LTP).
The GORE® VIAFORT Vascular Stent IVC Study
Venous ThrombosesVenous Disease8 moreThis study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
A PMCF Study Confirm the Performance and Safety of the TufTex Over-the-Wire (OTW) Embolectomy Catheters...
ThrombusEmbolus1 moreA PMCF study to confirm the performance and safety of the LeMaitre® TufTex Over-the-Wire Embolectomy Catheter
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study in Patients With Venous Thromboembolism...
Deep Vein ThrombosisPulmonary EmbolismNo randomized head-to-head comparison between the individual Non-vitamin K Antagonist Oral Anticoagulants (NOAC) exists. The DANNOAC-VTE study is a nationwide cluster randomized cross-over study comparing efficacy and safety of the four NOACs, edoxaban, apixaban, rivaroxaban and dabigatran for oral anticoagulation in venous thromboembolism across Danish hospitals.
TIPS vs Endoscopic Therapy for Variceal Rebleeding in Cirrhotic Patients With Portal Vein Thrombosis...
Portal Vein ThrombosisLiver Cirrhosisportal vein thrombosis may be a negative prognostic marker of variceal bleeding in liver cirrhosis. Compared with conventional endoscopic and pharmacological therapy, transjugular intrahepatic portosystemic shunt may further improve the outcomes of portal vein thrombosis in liver cirrhosis with variceal bleeding.
Compative Study of PE in Thrombosed AVF After Balloon Thrombectomy vs. Thromboaspiration.
Pulmonary Embolism and ThrombosisThe goal of this multicentric clinical trial is to compare the incidence of pulmonary thromboembolism (PTE), assessed through AngioCT, in the endovascular treatment of acute thrombosis in native and prosthetic arteriovenous fistulas (AVF). The main questions it aims to answer are: What is the difference in the incidence of pulmonary thromboembolism (PTE) assessed by AngioCT in endovascular treatment of acute thrombosis of native and prosthetic arteriovenous fistulas using balloon thrombectomy versus thromboaspiration systems? What is the primary patency rate of arteriovenous fistulas treated with balloon thrombectomy versus thromboaspiration systems? What is the clinical success rate in the treatment of arteriovenous fistulas using balloon thrombectomy compared to thromboaspiration systems? What are the costs associated with the different thrombectomy techniques in the treatment of arteriovenous fistulas? Participants will be underwent to balloon thrombectomy versus thromboaspiration systems. Researchers will compare the patients treated with balloon thrombectomy and thromboaspiration systems to see if the incidence of PE is comparable and to evaluate the primary and secondary patency rates of both thrombectomy techniques, the clinical technical success rate, and the costs associated with each technique.
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to...
Iliofemoral; ThrombosisThis is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for at least 14 days and no more than 60 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.
Renal Function After Stentgraft Treatment Of Abdominal Aortic Aneurysm
Aortic AneurysmAbdominal2 moreThis randomized controlled trial aim to determine the impact on renal function after treatment for infrarenal abdominal aortic aneurysm (AAA) with stentgrafts either with active supra- or infrarenal fixation.
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous ThromboembolismDeep Venous Thrombosis1 moreThis study is a prospective, multicenter, randomized controlled trial of an interventional strategy using the ClotTriever System to achieve and maintain vessel patency (ClotTriever Intervention Arm) versus conservative medical management using anticoagulation therapy alone (Conservative Medical Management Arm) in the treatment of subjects with symptomatic unilateral iliofemoral DVT. The study will collect data on demographics, comorbidities, details from the DVT diagnosis and treatment, and clinical outcomes through the 6-month follow up visit.