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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research aims to gather more information on the safety, effectiveness, and performance of the DynamX Coronary Bioadaptor System in treating patients with ischemic heart disease caused by new native coronary artery lesions. It focuses on a real-world patient population with coronary artery disease to confirm how well this device works and its safety when used in routine medical care. All participants in the study will receive at least one implant of the DynamX Novolimus-eluting Coronary Bioadaptor System during a percutaneous coronary intervention PCI procedure. The device will be used following the products instructions in a commercial setting. This registry monitors the devices performance and outcomes over time without altering the usual care process. During the study, patients will be followed to assess clinical outcomes such as device success, procedural success, and various cardiovascular events including myocardial infarction, revascularization, stroke, and death. These outcomes will be tracked at hospital stay, 30 days, and 12 months after the procedure. The study also collects data on the duration of dual antiplatelet therapy DAPT and will monitor device safety and effectiveness throughout the follow-up period, which extends up to 12 months and beyond.
Actively Recruiting
Researchers are evaluating the combination of brenetafusp IMC-F106C plus nivolumab compared to standard nivolumab regimens in people with previously untreated advanced melanoma who are HLA-A*0201-positive. This phase 3, randomized, controlled study aims to understand how these treatments perform in this specific group. The study focuses on improving progression-free survival and overall outcomes for participants with advanced melanoma. Participants are assigned to one of three groups one group receives a low dose of brenetafusp once weekly for 13 weeks, then every two weeks until Week 51, and every four weeks thereafter, along with nivolumab every four weeks another group receives a high dose of brenetafusp on the same schedule plus nivolumab the third group receives nivolumab alone or nivolumab combined with relatlimab every four weeks. The study includes a dose recommendation phase with changes made in November 2025 based on safety and efficacy data. During the study, participants undergo assessments including tumor measurements per RECIST 1.1, BRAF V600 mutation status evaluation, and performance status scoring. Researchers will monitor progression-free survival up to approximately 45 months, overall survival up to 57 months, and record adverse events, immune responses, and quality of life. The study involves regular dosing and long-term follow-up to evaluate treatment effects and safety.