Saint Laurent Du Var

Researchers are conducting an international, multicenter, prospective, non-randomized post-market clinical follow-up PMCF study to confirm and support the clinical safety and performance of the Coroflex4 ISAR NEO coronary stent system, which is a sirolimus-eluting stent. This study includes all consecutive patients treated with this stent in a real-world, non-selected population under daily clinical practice to meet EU Medical Device Regulation requirements. Participants receive treatment with the Coroflex4 ISAR NEO coronary stent system as intended by the manufacturer during their standard care for coronary artery disease or ischemic heart disease. The study observes patients treated with this device without randomization or control groups, focusing on its use in routine medical settings. During the study, participants will be monitored for safety and efficacy outcomes, including freedom from target lesion failure within 7 days after the procedure. Additional safety measures during percutaneous coronary intervention PCI will be tracked, such as avoiding stent dislodgement, balloon rupture, hypotube rupture, coronary perforation, coronary dissection, no reflow, and coronary thrombosis. The study involves informed consent and follows patients outcomes under normal clinical conditions until study completion.

This research aims to observe how the Maestro Platform is used in real-world laparoscopic surgeries. The study focuses on monitoring the safety and performance of this surgical assistance device, evaluating its impact during procedures. The research is sponsored by Moon Surgical and includes adult patients undergoing laparoscopic surgery. Participants will have laparoscopic surgeries performed using the Maestro Platform, which assists by positioning and holding the surgical scope and retractor as guided by the surgeon. Standard surgical techniques and equipment are used alongside the device. Surgeons can switch back to manual minimally invasive surgery or convert to open surgery if needed during the procedure. During the study, researchers will track adverse events related to the device or procedure, procedure completion without device failure, and various procedure details such as duration, recovery time, and surgeon satisfaction. Measurements include monitoring complications, pain after surgery, device preparation time, and human resource use. Participants are followed for 30 days to assess safety and recovery outcomes.

Researchers are collecting data from multiple centers in France to study cardioneuroablation as a treatment for patients with recurrent vasovagal syncope caused by strong cardioinhibitory effects. This observational registry aims to evaluate success rates, compare different techniques, and support institutions in establishing their own cardioneuroablation programs. Important questions include the procedures success, patient benefit, target sites for ablation, methods for identifying fat pads, and long-term effects. The study focuses on cardioneuroablation, a procedure using radiofrequency ablation to destroy cardiac ganglionated plexi in epicardial fat pads around the atria. Patients with recurrent vasovagal syncope who are scheduled for this procedure will be included. The registry collects data on the recurrence of syncope, efficacy of the procedure, post-ablation symptoms, correlation with ablation sites, patient quality of life, and technical learning curves at participating centers. Participants will be monitored for 12 months to track recurrence of vasovagal syncope and other outcomes. Data collection includes clinical history, procedure details, and follow-up assessments on quality of life and symptoms. The study helps to characterize patient outcomes and improve technical approaches. Participation involves no experimental treatment beyond the scheduled procedure, with data gathered during routine care and follow-up visits.

Researchers are evaluating the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in people with coronary artery disease who have atherosclerotic lesions longer than 36 mm and up to 44 mm in their native coronary arteries. The study focuses on lesions with a reference vessel diameter between 2.25 mm and 4.0 mm. This is a prospective, multicenter, single-arm study sponsored by Teleflex, aiming to treat subjects with these specific lesions using this device. Participants will receive the Orsiro Mission stent, which consists of a cobalt chromium stent platform coated with a bioabsorbable polymer containing the drug sirolimus. This device is designed to be implanted in the coronary arteries during percutaneous coronary intervention PCI. The study involves a single group receiving this stent to assess its performance in treating lesions of the specified length and size. During the study, participants will have follow-up visits to monitor outcomes and safety. Those enrolled in the United States will be followed for 2 years with visits at 1, 6, 12 months, and 2 years after the procedure. Participants outside the United States will be followed for 5 years with additional visits at 3 and 5 years. Researchers will measure target lesion failure at 12 months as the primary outcome and will also track device and procedure success, deaths, heart attacks, major cardiac events, revascularizations, and stent thrombosis throughout the follow-up period.