Deep Vein Thrombosis (DVT)

Researchers are evaluating the safety, effectiveness, and how the body processes different doses of JMKX003142 tablets in patients with renal edema. This phase 2 study is designed as a randomized, open-label, and active-controlled trial conducted in China. JMKX003142 is a drug that blocks arginine vasopressin V2 receptors and has shown strong diuretic effects in healthy volunteers. Participants will be randomly assigned to one of four groups: a low-dose, median-dose, or high-dose group of JMKX003142 tablets, or an active comparator group receiving torasemide tablets. All treatments are taken orally once daily for 7 days. The study aims to observe the safety, efficacy, and pharmacokinetic characteristics of these treatments. During the study, participants will have their body weight measured after 7 days as the primary outcome. Safety and efficacy will be monitored throughout the treatment period. Participants must be at least 18 years old and diagnosed with renal edema. The study includes regular assessments to ensure participant safety and adherence to treatment, with the trial expected to complete by July 2026.

Researchers are collecting and creating a labeled ultrasound image data set from patients undergoing routine ultrasound scans of their lower limbs due to suspected deep vein thrombosis (DVT). This observational study aims to gather imaging data, patient information, and ultrasound metadata to train artificial intelligence (AI) models that can automatically detect DVT from conventional ultrasound scans. The study is part of the ThrombUS+ project, which focuses on developing tools for early and automated DVT diagnosis to improve patient safety and outcomes. The study involves selecting patients suspected of having DVT who are referred for ultrasound scans. These patients, both inpatients and outpatients, will be consecutively included to ensure diversity of demographics, medical conditions, and ultrasound operators. The collected data will include ultrasound image series and video clips, along with anonymized patient demographics, referral notes, medical conditions, scan diagnoses, operator IDs, and ultrasound equipment details. The anonymized data set will be prepared according to regulations for research use and shared publicly through European science portals. Participants will undergo routine ultrasound scans for suspected DVT, and their scan data and related information will be collected and anonymized. The primary outcome is the ultrasound data collected on the day of the scan. The data set will support AI model training and research, with the anonymized information made available for further study. Participation involves providing informed consent and allowing the inclusion of their scan data and metadata. The study will monitor data quality and maintain privacy throughout, with no interventional treatments involved.

Researchers are evaluating the use of rivaroxaban, a blood thinner, in adults with superficial vein thrombosis (SVT) of the leg. This pilot study aims to test the study plan and see if enough participants will join a larger trial. It includes a small group and is not designed to prove safety or effectiveness, but to measure recruitment rates over 12 months. Participants will be randomly assigned to one of two groups. One group receives full-dose rivaroxaban for 90 days, starting with 15mg twice daily for 21 days, then 20mg once daily for 69 days. The other group receives a lower dose of rivaroxaban for 45 days combined with placebo pills to keep the study blinded, followed by 45 days of placebo alone. During the study, participants will be monitored to see how many join each month and how well the study procedures work. Researchers will track outcomes over 12 months, including recruitment feasibility and secondary measures from the start of recruitment until the last participant's follow-up. The study uses a randomized, double-blind design to evaluate these aspects.

This clinical investigation is a prospective, single-arm, multicenter post-market study designed to collect clinical data on the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheters. The study aims to confirm the device's performance in removing arterial emboli and thrombi, identify any emerging risks based on factual evidence, and ensure the continued acceptability of its benefit-to-risk ratio. The device is used for patients undergoing surgical treatment for emboli or thrombi removal, with the study sponsored by LeMaitre Vascular, Inc. The study involves using the LeMaitre TufTex OTW Embolectomy Catheter, which is intended for removing emboli and thrombi during embolectomy or thrombectomy. The catheter can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration. The investigation is planned to enroll 112 subjects across four sites in about three countries, with an enrollment period lasting 48 months. Each participant will be followed for one month after the procedure. The total study duration is approximately 56 months, including start-up, recruitment, follow-up, and closure phases. Participants will undergo surgical treatment using the catheter, and researchers will assess technical success defined as less than 30% residual stenosis one month after the procedure. Safety will be monitored during the procedure and follow-up. Additional outcomes measured include clinical success, revision rates, and vessel patency at one month post-procedure. The study includes monitoring for any adverse events to ensure safety and performance. Participation involves one month of follow-up after the surgical procedure to evaluate these outcomes.

Researchers are studying acute pulmonary embolism, a condition where blood clots block lung arteries, to predict possible serious outcomes within 30 days after hospital admission. This observational study collects clinical, laboratory, and CT scan data from patients diagnosed with acute pulmonary embolism. The goal is to develop a predictive tool using these data to identify patients at higher risk of adverse events. Patients diagnosed with pulmonary embolism by CT pulmonary angiography and aged 18 or older are included. Participants are divided into two groups: one to create and assess a prediction model using logistic regression, and the other to validate this model. The model's accuracy is compared to existing risk assessment systems, aiming to improve early identification of patients who may experience complications. During the study, clinical and imaging data, including CT scans and laboratory tests like cardiac troponin I and NT-pro BNP levels, are collected from admission. Researchers monitor outcomes over 7 and 30 days to evaluate the occurrence of adverse events. The study tracks participants' health status to assess the prediction tool's performance and safety throughout the monitoring period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CITY-FXI, a drug targeting Factor XI, in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation. This first-in-human, randomized, double-blind, placebo-controlled study aims to better understand how CITY-FXI works in these populations and its potential effects. The trial is sponsored by City Therapeutics and includes participants aged 18 to 60 years. The study consists of two parts: Part A involves single ascending doses of CITY-FXI or placebo given by subcutaneous injection to healthy adults, and Part B includes similar dosing in adults diagnosed with FVL or prothrombin G20210A mutation. Women of childbearing potential in Part B must use highly effective contraception. The doses will be increased in a controlled manner to assess safety and drug behavior. Participants will be monitored for adverse events throughout the study, up to 360 days after dosing. Researchers will measure drug levels in the blood and urine shortly after dosing, and track changes in blood clotting factors and activity over time. Study visits will include physical exams, laboratory tests, and safety assessments to evaluate treatment effects and participant well-being over the follow-up period.

Researchers are evaluating the efficacy and safety of three different dose levels of SRSD107 compared to enoxaparin 40 mg daily in adults aged 60 to 80 undergoing elective primary unilateral total knee arthroplasty (TKA). This Phase 2, multicenter, randomized, open-label study includes a blinded endpoint evaluation and aims to find the best dose of SRSD107 for preventing venous thromboembolism (VTE) after surgery. Participants will be assigned to one of four groups: low, medium, or high single subcutaneous doses of SRSD107, or enoxaparin 40 mg subcutaneously once daily for 12 ±2 days after surgery. The identity of the study drug is known, but the specific SRSD107 dose is blinded. Up to approximately 450 subjects will be randomized to these groups. During the study, participants will take the study drug at least 28 days before surgery and attend clinic visits, including venography 10 to 14 days after TKA. Researchers will monitor the incidence of total VTE events from surgery through 12 ±2 days post-surgery as the primary outcome. Secondary outcomes include major VTE, bleeding events, and adverse events up to Day 169. Safety and efficacy assessments will continue throughout the study period, which ends in October 2026.

Researchers are collecting and evaluating clinical data on various Abbott vascular medical devices used for conditions such as acute myocardial infarction, coronary artery lesions, restenoses, venous embolism, and arterial embolism. This prospective, non-randomized, open-label, multi-center registry aims to confirm the safety and performance of these devices over their expected lifetime. The study also focuses on monitoring identified risks, detecting new risks based on actual evidence, ensuring the benefit-risk balance remains acceptable, and identifying any misuse or off-label use of the devices. Participants are grouped based on the type of device used in their vascular procedure. These devices include coronary and peripheral stents, pacing catheters, vascular plugs, measurement and imaging tools (FFR and OCT), peripheral and coronary dilatation catheters, coronary and peripheral guidewires, vessel closure/compression devices, and vascular access introducers. Each participant receives the device relevant to their treatment as part of their procedure. During the study, researchers track participants from the start of their procedure, defined as the time a guidewire first enters the vasculature, until vessel closure following the procedure. They monitor outcomes such as death, myocardial infarction, target lesion revascularization, device-related complications, and procedural success at various points including during the procedure, at 30 days, and at 12 months. Participants are expected to follow a specified follow-up schedule to provide data on device safety and performance throughout the study duration, which runs until November 2031.

Researchers are evaluating the Methinks Stroke Suite, an AI-based imaging software, to see if it can help speed up the transfer of acute stroke patients who may need thrombectomy from local stroke centers to specialized centers. The study focuses on patients initially assessed at centers that cannot perform endovascular therapy (EVT). The main goals are to find out whether the software reduces the time to decide on patient transfer and how accurately it identifies candidates for EVT. The study compares patient care after integrating Methinks Stroke Suite into the stroke workflow with a historical group treated before its use. Patients will have a CT scan analyzed by the AI software at the local center. If the software and clinical judgment suggest thrombectomy might be needed, patients are transferred to specialized centers. If no large vessel occlusion is detected, further imaging like CT angiography may be done to reassess. This is an open-label, quasi-experimental study conducted across multiple centers in Catalonia, Spain. Participants will undergo CT scans at their local stroke center, with imaging data processed by the Methinks software. They will be followed for 90 days after their stroke to assess recovery and functional outcomes. Researchers will measure time from arrival to transfer decision, evaluate the software's accuracy in detecting large vessel occlusions, monitor treatment rates, and gather clinician feedback on using the software. Safety during patient transfers will also be tracked. The study plans to enroll about 250 patients and includes a follow-up period of 3 months after stroke.

This study is an observational, monocentric, retrospective and prospective research aimed at evaluating the feasibility of mechanical thrombectomy in adult patients with symptomatic acute or subacute iliofemoral or caval deep vein thrombosis (DVT). The condition is diagnosed with CT scan imaging, and the study follows clinical practice guidelines for patients with proximal DVT in veins such as the inferior vena cava, iliac vein, and femoral veins. Participants will undergo mechanical thrombectomy treatment after receiving anticoagulation therapy with enoxaparin sodium for at least 48 hours prior to the procedure. The access site for the procedure is chosen based on the extent of the blockage, with popliteal vein access used for single limb treatment. After the procedure, catheters are removed, pressure is applied to the insertion site, and pressure bandages are placed on both legs until hospital discharge. Anticoagulation therapy continues until discharge. During the study, participants will have duplex imaging and laboratory tests within 24 hours after treatment completion. Adverse events will be collected as part of the safety monitoring. The primary outcomes measured include the rate of technical success at the end of the procedure and the number of participants experiencing bleeding within 72 hours post-thrombectomy. All visits and procedures are conducted according to normal clinical practice, and the study is expected to run until December 2027.