Kyle

This research aims to evaluate the long-term safety of pirtobrutinib in people who have previously been treated for chronic lymphocytic leukemia CLL or small lymphocytic lymphoma SLL. It offers continued access to the study drug or follow-up for participants who completed a prior related study LOXO-BTK-20020. The study is designed to observe and monitor safety outcomes over an extended period. Participants receive either pirtobrutinib or idelalisib orally as part of the study treatments. These medications are taken every four weeks. The study is expected to last about five years, allowing researchers to collect long-term safety data on these treatments in a parallel group setup. Throughout the study, participants will have regular visits to monitor their health and any treatment-related effects. Researchers will track the percentage of participants experiencing serious treatment-emergent adverse events. They will also observe overall survival from the original study enrollment. Safety monitoring will continue up to 30 days after the last dose or until new anticancer therapy begins, ensuring careful follow-up for each participant.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

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 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.

Researchers are conducting a prospective, multi-center, single-blind, randomized study to compare two devices for treating coronary artery in-stent restenosis ISR. The study aims to evaluate whether the Virtue4 Sirolimus AngioInfusion12 Balloon SAB performs no worse than the AGENT12 Paclitaxel Drug-Coated Balloon DCB in improving clinical outcomes for patients with ISR, a condition where narrowing occurs inside previously placed stents in coronary arteries. Participants will be randomly assigned to receive treatment with either the Virtue SAB device or the AGENT Paclitaxel DCB during a percutaneous coronary intervention PCI procedure. The study compares these two balloon devices in a parallel design, with patients undergoing angioplasty using one of the devices. Treatment is focused on a single critical ISR lesion in a native coronary artery, covering lesions with specific size and severity criteria. During the trial, participants will be monitored for clinical outcomes, especially target lesion failure TLF at 12 months after treatment. Researchers will assess treatment success and safety through follow-up visits, collecting relevant clinical data over time. The total study completion is planned by October 2032, with primary outcome assessment expected by October 2028.