Kankakee

Researchers are evaluating the effect of ataciguat on slowing the progression of moderate calcific aortic valve stenosis (CAVS) in adults. This study is divided into two parts: Part A focuses on whether ataciguat reduces aortic valve calcium buildup, and Part B investigates whether ataciguat slows loss of aortic valve area and improves peak oxygen consumption. The study also assesses safety, tolerability, and pharmacokinetics of ataciguat in these participants. Participants will receive either ataciguat or a placebo daily for up to 156 weeks. Part A will enroll about 132 adults with moderate CAVS, while Part B will enroll approximately 1144 participants following completion of Part A. The study is randomized, double-blinded, and placebo-controlled, designed to provide detailed information on ataciguat's effects over time. Throughout the study, participants will undergo non-contrast CT scans to measure aortic valve calcium, echocardiograms to assess valve area, and cardiopulmonary exercise testing to evaluate peak oxygen consumption. Safety and tolerability will be monitored continuously. The primary outcomes include changes in aortic valve calcium at 24 weeks, and changes in aortic valve area and peak oxygen consumption at 48 weeks, with long-term participation lasting up to 156 weeks.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.