Arnsberg

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating the use of the ClotTriever System compared to standard anticoagulation therapy for treating symptomatic unilateral iliofemoral deep vein thrombosis DVT. This trial is a prospective, multicenter, randomized controlled study that aims to compare clinical outcomes between an interventional device strategy and conservative medical management. The study will enroll approximately 300 participants and collect detailed data on demographics, comorbidities, DVT diagnosis, treatment, and clinical outcomes through a six-month follow-up. Participants will be randomly assigned to one of two groups the ClotTriever Intervention Arm, where the ClotTriever System device is used for mechanical thrombectomy to restore and maintain vessel openness, or the Conservative Medical Management Arm, where patients receive anticoagulation therapy alone with medications such as heparin, warfarin, rivaroxaban, or apixaban. The study compares these two approaches to determine their effects on treatment outcomes in symptomatic unilateral iliofemoral DVT. During the study, participants will undergo assessments including clinical evaluations at specified time points up to 180 days to measure a composite clinical endpoint using a win ratio method. Additional evaluations will include assessment of post-thrombotic syndrome severity and monitoring for safety and treatment effects. Participants must be willing and able to attend follow-up visits over the six-month period to provide data for the studys outcome measures.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

Researchers are evaluating the safety and clinical performance of the Oscar Peripheral Multifunctional Catheter in patients with peripheral arterial disease affecting the femoral, popliteal, and infrapopliteal arteries. This prospective, multicenter, observational study aims to confirm procedural success and monitor in-hospital complications such as vessel perforation, rupture, acute occlusion, and distal embolization. The study includes patients with significant artery narrowing and specific lesion characteristics, who require endovascular intervention. The study uses 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 device is used to dilate lesions in the target arteries. The study focuses on procedural outcomes such as successful crossing of the target lesion, residual stenosis after vessel preparation, and absence of procedural complications. Treatments of inflow lesions may be performed before the target lesion treatment according to local standards. Participants will undergo the index procedure where procedural success and complications are closely monitored. Assessments include measuring procedural success rates, rates of adverse device effects, distal embolization, vessel rupture, perforation, and acute occlusion, as well as flow-limiting dissections and amputation occurrences within 30 days. Data on residual stenosis and crossing success will be collected. The study period extends until January 2026, with follow-up evaluations up to 30 days after discharge.

Researchers are evaluating the safety and effectiveness of the SELUTION SLR14 Drug Eluting Balloon DEB compared to plain uncoated balloon angioplasty in patients with peripheral arterial disease PAD affecting the below-the-knee BTK arteries, specifically in those with chronic limb-threatening ischemia CLTI. The study aims to show that the SELUTION SLR14 DEB has better efficacy and similar safety compared to the uncoated balloon treatment. Participants are adults aged 18 years or older with documented CLTI and significant narrowing in BTK arteries. The trial randomly assigns participants to one of two groups one receiving the SELUTION SLR14 DEB and the other receiving plain balloon angioplasty. Both are non-surgical procedures where a catheter inflates a balloon to open narrowed arteries below the knee. Treatments target specific lesions in BTK arteries and must meet detailed angiographic criteria. The study uses a single-blind design and includes follow-up assessments over several years. Participants will undergo evaluations at multiple time points including 30 days, 6 months, and up to 36 months after treatment. Assessments include clinical improvement, amputation rates, wound healing, imaging, and quality of life measures. Safety endpoints are monitored early, while efficacy outcomes are tracked long term. The study also evaluates device and procedural success immediately after treatment. Overall participation may last over three years to gather comprehensive safety and effectiveness data.