Ashland

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.

Researchers are studying a device called the GORE VIABAHN VBX Balloon Expandable Endoprosthesis to treat people with complex iliac occlusive disease, a condition affecting blood flow in the iliac arteries. This clinical trial is designed to compare this device to bare metal stenting, aiming to see which approach better keeps the arteries open over time. The study is prospective, multicenter, randomized, and controlled with a double masking design. Participants will be randomly assigned to one of two groups one receiving the GORE VIABAHN VBX device and the other receiving a commercially available bare metal stent approved for this condition. Treatments focus on the common andor external iliac arteries with lesions between 4 and 11 cm and vessel diameters between 5 mm and 13 mm. Both groups will receive stenting procedures using these devices. During the trial, participants will undergo evaluations to measure artery openness primary patency at one year and up to five years. Additional measures include technical and clinical success of procedures, hemodynamic status, quality of life changes, freedom from restenosis and revascularization, amputation-free survival, and overall survival. The study involves follow-up visits over several years to monitor these outcomes and safety.