Arnsberg

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating two treatment approaches for people with symptomatic unilateral iliofemoral deep vein thrombosis (DVT), a condition involving blood clots in the large veins of the leg. This study is a prospective, multicenter, randomized controlled trial comparing an interventional procedure using the ClotTriever System to remove clots and keep blood vessels open against standard medical care using anticoagulation medication alone. The trial aims to understand which treatment leads to better clinical outcomes over six months. About 300 participants will be randomly assigned to one of two groups: the ClotTriever Intervention Arm or the Conservative Medical Management Arm. Those in the ClotTriever group will receive mechanical thrombectomy with the ClotTriever System, while the other group will be treated with approved anticoagulant drugs such as Heparin, Coumadin, Rivaroxaban, or Apixaban. Both treatments focus on managing the clot and restoring vessel patency, with follow-up visits scheduled through a 6-month period. Participants will be monitored closely with data collected on demographics, medical history, DVT diagnosis details, and treatment outcomes. The main outcome measured is a combined clinical endpoint evaluated at about 180 days, focusing on the effectiveness of each treatment strategy. The study also includes regular follow-up assessments to track health status, potential complications, and treatment safety throughout the six months after enrollment.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in treating lesions in the femoral, popliteal, and infrapopliteal arteries. This observational study focuses on patients with peripheral arterial disease and aims to confirm procedural success rates and monitor in-hospital complications related to endovascular interventions. The study includes a wide range of patients undergoing standard care practices for these artery lesions. The treatment involves using the Oscar Peripheral Multifunctional Catheter, which includes three components: the Oscar Support Catheter with integrated Lock Grip, the Oscar Dilator, and the Oscar PTA Balloon. The balloon can also be used separately but only with the pre-supplied support catheter. The procedures target lesions located either above or below the knee, and certain vascular inflow lesions may be treated during the same procedure according to local standard care. Participants will be involved in the study by undergoing endovascular procedures using the catheter, with researchers monitoring procedural success defined by lesion crossing and residual stenosis under 30%, and absence of complications like vessel perforation or embolization. The study collects data on procedural outcomes and complications during hospital stay. The primary outcome measure is the success rate of the procedure using the Oscar device. Participants must be adults aged 18 or older and will be observed during their treatment and hospitalization period.

Researchers are evaluating the safety and effectiveness of the SELUTION SLR14 drug-eluting balloon compared to a plain (uncoated) balloon angioplasty for treating peripheral arterial disease in below-the-knee arteries of patients with chronic limb-threatening ischemia. The study aims to show better treatment success with the drug-eluting balloon while maintaining similar safety. Eligible patients have significant artery narrowing and symptoms lasting more than two weeks. Participants will receive either the SELUTION SLR14 drug-eluting balloon or the plain balloon during a non-surgical procedure where a catheter inflates the balloon to open narrowed arteries below the knee. The study focuses on lesions in specific below-the-knee arteries and follows strict criteria for lesion size, location, and vessel condition. The treatments are delivered through minimally invasive catheter techniques. During the study, participants will be monitored for safety up to 30 days and for treatment effectiveness over 6 months. Assessments include imaging to confirm artery opening, clinical evaluations, and follow-up visits to track healing and limb function. The study also observes for complications or adverse events to ensure participant safety throughout the trial.

This research aims to collect data on the safety and performance of the SoundBite Crossing System XS Peripheral device in treating people with calcified chronic total occlusions in arteries of the extremities. The study focuses on patients who are scheduled for interventional treatment of occlusions in native arteries below the inguinal region, including a sub-study for blockages below the knee. Participants have chronic total occlusions with no blood flow beyond the blockage except through collateral circulation and present symptoms such as claudication or critical limb ischemia. Participants will receive treatment using the SoundBite Crossing System device, which is designed to cross calcified chronic total occlusions. The study includes patients with moderate or more severe calcification of the target lesion according to a specific classification and those whose lesions have not been successfully crossed with a guidewire before. This is a non-randomized, open-label study conducted at multiple centers. During the study, researchers will monitor device performance and safety on the day of treatment. Participants must be at least 19 years old and will be followed as they undergo treatment. Safety evaluations will consider any medical conditions that could affect candidacy for intervention, and outcomes will be assessed based on the device's ability to cross the occlusions safely and effectively.